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3.0 - 5.0 years

6 - 10 Lacs

bengaluru

Work from Office

Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities A day in the life of an Infoscion As part of the Infosys consulting team, your primary role would be to actively aid the consulting team in different phases of the project including problem definition, effort estimation, diagnosis, solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys, information available in public domains, vendor evaluation information, etc. and build POCs You will create requirement specifications from the business needs, define the to-be-processes and detailed functional designs based on requirements. You will support configuring solution requirements on the products; understand if any issues, diagnose the root-cause of such issues, seek clarifications, and then identify and shortlist solution alternatives You will also contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers. If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Preferred Skills: Technology->ETL & Data Quality->ETL - Others

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7.0 - 11.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As a valuable member of a dynamic R&D team, you will be contributing to seamless technology transfer, innovative product development, and continuous quality enhancement for successful commercialization of pharmaceutical products across solid, semisolid, and liquid dosage forms. Your responsibilities will include leading and coordinating technology transfer from R&D/CRO to manufacturing sites, monitoring site activities, troubleshooting manufacturing issues, overseeing formulations for quality improvement, and developing new products through pre-formulation, competitor evaluation, formulation development, and stability studies. To excel in this role, you should possess expertise in technology transfer processes for multiple dosage forms, strong project management and coordination skills, the ability to handle multiple projects simultaneously, problem-solving capabilities in manufacturing environments, and proficiency in documentation, validation, and regulatory compliance. The ideal candidate will hold a M. Pharm / B. Pharm degree and have 7-10 years of experience in pharmaceutical R&D. A proven track record in technology transfer and new product development, as well as experience in solid, semisolid, and liquid dosage forms, will be advantageous for this position.,

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8.0 - 12.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Team Lead for Downstream Process development of Vaccines, your primary responsibility will be to achieve R&D development targets in alignment with organizational and market requirements. You will be managing the planning, implementation, and management of R&D development methods for new products and technologies, encompassing both upstream and downstream methods for large scale Bacterial & Viral Vaccine Production. Your role will require you to be a subject matter expert in Bacterial & Viral Vaccine Process development, possessing a thorough knowledge of downstream processes for vaccines and staying informed about current developments in the vaccine industry. You should be competent in creating strategies for downstream process development, managing multiple projects within the group, and utilizing expertise in cell separations, cell lysis, protein refolding, Chromatography techniques, filtration, and other relevant methods. Additionally, you will be expected to contribute unique ideas aimed at reducing process/product costs and demonstrate an understanding of protein chemistry to optimize the purification process. Your familiarity with technology transfer, scale-up processes, and the preparation/review of technical dossiers for regulatory submissions will be crucial in this role. As the Team Lead, you will be accountable for project conception and execution, representing the function at project meetings, and collaborating with various departments such as regulatory, ADL, PMT, Mfg., and QA for GMP/GLP activities. Your responsibilities will also include directing teams to achieve research objectives, monitoring performance to meet timeline targets, and coordinating with project management for planning, budgeting, and commercialization of products. Moreover, you will drive organization and culture building initiatives, support the development of values and desired behaviors within the team, review performance management decisions, and facilitate career planning for team members. Your role will involve guiding training initiatives, knowledge management practices, exposure to best practices, and participating in structured coaching programs to recruit and develop talented individuals.,

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6.0 - 15.0 years

0 Lacs

karnataka

On-site

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable, and more connected world. As a Sr. Principal Engineer, you will play a crucial role in leading the identification, development, and management of strategic external partnerships to bring new and differentiated capabilities to the high-speed interconnect industry. This position is at the core of our Advanced Technology strategy, aiming to bridge cutting-edge research, market demands, and manufacturing readiness to drive innovation in high-speed connectivity products. Your responsibilities will include identifying, evaluating, and establishing external partnerships that deliver unique capabilities in high-speed interconnects. You will lead complex technology and process development programs, serving as the primary point of contact with external partners. Additionally, you will drive the integration of external innovations into TE's advanced technology and manufacturing process roadmap. To excel in this role, you should possess an advanced engineering degree and have over 15 years of experience, demonstrating a successful track record in developing and leading external collaborations. Direct experience with high-speed connectivity products, such as connectors, cables, optical/electrical interconnects, is highly preferred. Your background should reflect expertise in technology readiness levels, commercialization processes, stakeholder management, and project management, particularly in AI, datacenter, or telecom sectors. You will be required to establish partnership agreements, including IP rights, and development plans/schedules. It is essential to apply effective risk management strategies to mitigate technical, schedule, and partnership-related challenges. Your ability to interpret complex technical data to facilitate decision-making processes will be crucial for success in this role. The ideal candidate will possess excellent verbal and written communication skills in English, enabling effective presentation and influence at all levels. You should also demonstrate proficiency in working within multi-cultural teams and across boundaries to deliver complex initiatives. Familiarity with manufacturing processes such as molding, stamping, plating, and high-speed cable/cable assembly manufacturing is advantageous. In summary, the Sr. Principal Engineer role at TE offers a unique opportunity to drive innovation and collaboration in the high-speed interconnect industry, contributing to the advancement of technology and connectivity solutions for a more connected world.,

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6.0 - 10.0 years

0 Lacs

punjab

On-site

You will be responsible for mapping potential customers and generating leads for a Podcast, as well as generating new opportunities such as sponsors and building the Podcast. Meeting the sales targets of the organization through effective planning and budgeting will be a key aspect of your role. You will need to devise strategies and techniques necessary for achieving the sales targets and conduct distribution channel analysis and development. Additionally, you will be involved in new product development planning and management, technology transfer, licensing, partnerships assessment and development, as well as marketing, advertising, and promotion planning for the Podcast. Sales organization planning and development, generating business plans and strategies, and ensuring appropriate administration, budgeting, monitoring, reporting, communication, and liaison are also part of your responsibilities. Self-development and continuing personal development will be encouraged and supported. Qualifications: - Minimum 6+ years of experience in sales management - Ability to close deals - Fast learner and quick thinker - Ability to manage a team and ensure team productivity - Competency in English, Hindi & Punjabi - Flexible to work in the field and shifts - Ability to negotiate and well-versed with marketing skills - Self-motivated and goal-oriented, with a desire to deliver results - Ability to create and deliver presentations - Ability to adapt and grow in a competitive environment In this role, you will play a crucial part in driving sales and business development for the Podcast, utilizing your skills and experience to contribute to the growth and success of the organization.,

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3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a bench scientist at our organization, you will be responsible for conducting experimentation in the field of formulation research and development for global markets. Your role will involve working with scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be required to analyze data from literature reviews and effectively present information for decision-making purposes. Understanding the Intellectual Property (IP) scenario and working on design strategies, prior art searches, and establishing proof of concept through experiments will be a key part of your responsibilities. You will collaborate with cross-functional teams and coordinate with various departments for technology transfer and timely execution of submission batches. Your problem-solving skills will be put to the test as you identify challenges, bottlenecks in development, and propose mitigation strategies at different stages of the development process. Prioritizing activities, conducting lab experiments, and participating in the execution of development trials will be integral to your day-to-day tasks. Aligning your activities with established milestones, ensuring clear communication with internal stakeholders, and working towards achieving Business Unit Key Performance Indicators (KPIs) are essential aspects of this role. You will also assist in evaluating business processes, identifying areas for improvement, and demonstrating personal accountability and effective work habits. Your day-to-day activities will include working closely with the formulation development teams, conducting experiments in line with QbD principles, preparing presentations at various stages of product development, and conducting literature reviews and experiment designs. You will be responsible for evaluating API & Excipients sources, conducting preformulation studies, executing development trials, and interpreting analytical data for further action plans. Additionally, you will play a crucial role in the execution of Pilot Bioequivalence (BE) batches, scale-up batches, and exhibit batches at different manufacturing locations. Your expertise in establishing stability data, preparing various documents, coordinating with cross-functional teams, and ensuring regulatory compliance will be vital for the successful development and launch of generic drug products. To qualify for this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 3 years of experience or an M.Pharm in Pharmaceutical Sciences with 6 years of experience from reputed universities. Experience in working with generic products in regulated markets such as the US, EU, or Canada is preferred. Your technical skills should include expertise in Formulation Development of Solid Oral Dosage forms, knowledge of recent ICH and regulatory guidelines, and understanding of Bioequivalence, GMP, Quality, and SOP compliance. Strong people skills, interpersonal skills, and the ability to work both independently and collaboratively with teams are essential for this role. If you are confident, detail-oriented, and passionate about making a difference in the pharmaceutical industry, we invite you to join our team and contribute to our mission of improving global health outcomes through affordable and accessible medicines.,

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3.0 - 7.0 years

0 Lacs

kolkata, west bengal

On-site

We are seeking a highly motivated and detail-oriented Quality Management System (QMS) professional to join our Quality Assurance team at Mendine Pharmaceuticals Pvt Ltd. As a part of our team, you will play a crucial role in ensuring compliance with regulatory requirements and company standards by implementing and maintaining effective quality management systems. Your responsibilities will include managing various quality-related activities such as quality risk management, batch manufacturing record preparation, process validation, deviation management, and more. In your role, you will be expected to identify, assess, and mitigate quality risks associated with products and processes. You will also be responsible for implementing and maintaining a quality risk management system in alignment with regulatory guidelines. Additionally, you will prepare and review Batch Manufacturing Records (BMRs) to ensure accuracy and compliance with regulatory requirements, as well as coordinate and execute process validation activities while ensuring compliance with regulatory standards. Furthermore, you will develop and maintain packaging material specifications, prepare and review Annual Product Quality Reviews (APQRs), coordinate cleaning validation activities, manage deviations from established processes and procedures, oversee change control activities, prepare batch cards, and coordinate technology transfer activities. Collaboration with Regulatory Affairs (RA) and Research & Development (R&D) teams on quality-related matters will be essential to ensure effective communication and coordination on quality-related activities. To be successful in this role, you should possess a Master's degree in Pharmacy along with a minimum of 3-7 years of experience in a QA/QMS role within the pharmaceutical industry. Strong knowledge of regulatory requirements such as cGMP, ICH, and ISO 9001 is necessary, along with excellent analytical, problem-solving, and communication skills. The ability to work independently and lead cross-functional teams will also be vital for this position. As part of our team, you will receive a competitive salary based on your present package and industry norms, along with opportunities for professional growth and development in a collaborative and dynamic work environment. If you are an eligible, motivated, and detail-oriented professional with a passion for quality management, we invite you to submit your application for consideration.,

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6.0 - 15.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this position should have a total work experience of 15 years, with 6.5 years of experience in the current role. The candidate should possess a background in Formulation Development, Technology Transfer, Root Cause Investigations, and Project Management. As a Technology Transfer Specialist, your primary responsibility will be to drive technology transfer for Third-party manufacturing, Loan license projects, and Abbott's manufacturing plants. You will also be required to support Abbott site MS&T team as per the project requirements and assist in the qualification of alternate suppliers for raw materials & API. Ensuring compliance with regulatory, quality, statutory, EHS, and Pharmacovigilance requirements will be a crucial part of your role. Your core responsibilities will include conducting a thorough gap analysis between the sender and receiving sites in terms of processes and equipment to facilitate smooth technology transfer. You will be responsible for preparing Master Formula Record and Technology Transfer Protocol for products identified for transfer and reviewing draft documents related to manufacturing, process validations, and product analysis. Additionally, you will execute validation batches and ensure reproducibility in commercial batches, review process validation batch documents, and provide support for FLQR approvals. Furthermore, you will troubleshoot and resolve production process issues at the manufacturing site, investigate commercial batch failures or market complaints, and contribute to appropriate CAPA implementation. Conducting due diligence of new sites, improving knowledge base for handling Parenteral products, extending technical support for Alternate Supplier Qualification and Material Harmonization activities, and authoring, reviewing, and approving technical documents will be part of your routine tasks. You will also support NPI activities like Dossier review, Product certification, and FLQR approval, assist in new product launches, batch monitoring, and FLQR approval, and keep track of ongoing projects while updating senior management in advance. Your role will encompass a wide range of responsibilities aimed at ensuring successful technology transfer and compliance with industry standards and regulations.,

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13.0 - 17.0 years

0 Lacs

palghar, maharashtra

On-site

The ideal candidate for this position will join our R&D/F&D team focusing on Oral Solid Dosage (OSD) forms, including pellets and tablets. You will be responsible for conducting pre-formulation and formulation development studies, process validation, stability studies, and technology transfer of new pharmaceutical products while ensuring adherence to ICH guidelines and internal SOPs. Your key responsibilities will include conducting detailed literature reviews to support new product development initiatives. You will evaluate reference products, patents, regulatory status, and formulation strategies. Additionally, you will perform physicochemical characterization of API and excipients, assess compatibility, solubility, and stability as part of pre-formulation studies. In the formulation development phase, you will design and develop robust formulations for tablets and pellets. You will optimize process parameters through laboratory and pilot-scale trials. Stability studies will be conducted following ICH guidelines and internal SOPs, where you will interpret results and recommend necessary formulation or process adjustments. You will coordinate and execute process validation batches in the production department, ensuring compliance with GMP and validation protocols. Technology transfer responsibilities will include preparing and reviewing complete technology transfer documentation (TTD) and facilitating successful scale-up and handover of developed products to manufacturing. In case of troubleshooting, you will provide technical support for commercialized products to resolve formulation or process issues. Documentation and record-keeping tasks will involve preparing and updating Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly. Additionally, you will draft and review documents such as QAQN (Quality Assessment & Qualification Note), MFR (Master Formula Record), and FPS (Finished Product Specification). Qualifications required for this position include a B.Pharm/M.Pharm in Pharmaceutics or Pharmaceutical Technology and 13 years of relevant experience in F&D/R&D, preferably in OSD (tablets/pellets) formulation development in a regulated environment.,

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10.0 - 14.0 years

0 Lacs

karnataka

On-site

Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global health Novo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you'll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). Apply Now! As a Manufacturing Specialist (SME), you'll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include leading cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. You will also act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Additionally, you will provide training, share best practices, and review and approve validation documents to safeguard compliance while offering oversight and support during the planning and execution of validation and qualification activities. In this role, you will define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. You will be responsible for driving problem-solving initiatives and providing scientific and technical solutions within tight project timelines. To qualify for this position, you should have a Bachelors/Masters degree in engineering and possess at least 10+ years of experience with relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. You should be capable of communicating naturally and effectively with stakeholders at all levels, adept at finding solutions, and motivating stakeholders to achieve ambitious goals. A strong mindset, a focus on continuous improvement, and keen attention to detail are essential for success in this role. You should demonstrate the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. The GCM DP RoW Projects department is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you'll join a diverse and dynamic team committed to making a difference. Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're changing life. To submit your application, please upload your CV online (click on Apply and follow the instructions). The deadline for application submission is 8 August 2025. Novo Nordisk does not extend unsolicited employment offers and does not charge prospective employees with fees or make requests for funding as part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and communities we operate in. Together, we're life-changing.,

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6.0 - 15.0 years

0 Lacs

maharashtra

On-site

As an experienced professional with a total of 15 years of work background, including 6.5 years in your current role, you will be responsible for driving technology transfer for Third party manufacturing, Loan license projects, and Abbotts own manufacturing plants. You will support the Abbott site MS&T team as needed and assist in the qualification of alternate suppliers for raw materials & API. Your role will also involve ensuring compliance with regulatory, quality, statutory, EHS, and Pharmacovigilance requirements. Your primary job function will require you to perform effective gap analysis between sender & receiving sites in terms of process & equipment, and provide solutions for smooth technology transfer. You will be responsible for preparing Master formula record & Technology transfer protocol for products identified for transfer, reviewing draft documents from receiving sites, and executing validation batches to demonstrate reproducibility in commercial batches. Additionally, you will troubleshoot and solve production process problems, contribute towards investigations of batch failures or complaints, and support new site due diligence, product acquisitions, and certifications. Your core responsibilities will also include improving knowledge in handling Parenteral products and other dosage forms, providing technical support for activities like Alternate Supplier Qualification and Material Harmonization, reviewing and approving change controls and technical documents, and supporting NPI activities such as Dossier review, Product certification, and FLQR approval. You will also extend support to I&D for new product launches, batch monitoring, and keeping track of ongoing projects to update senior management in a timely manner.,

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3.0 - 5.0 years

3 - 5 Lacs

Hyderabad, Telangana, India

On-site

We are seeking a dynamic and experienced person in Process Development Plan and execute process optimization trials & to execute scale up/ confirmatory batch and to support pilot batch, exhibit batches by applying various engineering concepts during optimization and scale up. Roles & Responsibilities You will be responsible for providing critical inputs in process design, executing experiments, and collecting and interpreting data to facilitate smooth process scale-up and ensure effective process control. This role involves collaborating with cross-functional teams, utilizing Quality by Design (QbD) principles, and finalizing batch sizes and equipment trains for successful scale-up and technology transfer. You will be responsible to demonstrate successful process scale up to ensure smooth execution of confirmatory & exhibit Batches on time. You will be responsible to prepare documents required for confirmatory/ scale up batch at plant. Perform Scale Up correlations for all unit operations from lab scale to plant scale. And provide control strategy for Exhibit Batches based on Confirmation Batch (CB) results. You will be responsible to prepare Process optimization report & filing documents. You will be responsible to analyse data and provide support in answering process related deficiencies ensuring on time response to regulatory agencies. You will be responsible to develop process capabilities within team, train new joinee /freshers. Willingness to imbibe young talent and support in the initial stages. Qualifications Educational qualification: Masters/Bachelors/Ph.D in pharma Minimum work experience: 3-5 years of experience in Process development Skills & attributes: Technical Skills Experience in the development/ scale up/ technology transfer of products in relevant dosage forms or technologies. Understanding of pharmaceutical process selection Ability to prepare technical protocols and reports. Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches. Knowledge of International Council for Harmonisation (ICH) guidelines related to Product development or Process Development. Experience in Formulation Development understanding of execution methodology (based on Critical Material Attributes, Critical Quality Attributes of products. Experience in Analytical Research and knowledge on interpretation of the data. BehavioralSkills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Performance oriented and good at building, leveraging relationship. Ability to work collaboratively with own team and cross-functional teams. Committed to Learning & Coaching the team.

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6.0 - 8.0 years

6 - 8 Lacs

Chandigarh, India

On-site

We are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes, including authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis. Your role will involve active participation in technology transfers, continuous improvement initiatives, and ensuring compliance across manufacturing operations. Roles & Responsibilities Responsible for Validation which shall include:Preparation/Review/Approve of MPR.Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report. Responsible for Tech transfer which shall include: Coordination with Vendor/cross functional teams for Tech transfer activities.Execution of Tech transfer products at Receiving Units. Responsible for QIP which shall include: Identifying root cause for QIP.Execution of QIP. Conclusion/Recommendation of QIP. Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT. Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements. Follow up & coordinate with cross functional team for execution of validation. Give the input for the monthly reporting system, participate in the internal & external audits, present the documents to auditor's/inspection team. Qualifications Educational qualification: Masters/Bachelors/Ph.D in pharma Minimum work experience: 6 -8 years of experience in Process development / MSAT / Tech transfer Skills & attributes: Technical Skills Experience in the scale up/ technology transfer of products in relevant dosage forms or technologies. (OSD) Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches. Knowledge of International Council for Harmonization (ICH) guidelines related to Product development or Process Development.

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9.0 - 15.0 years

9 - 15 Lacs

Bengaluru, Karnataka, India

On-site

Dr Reddys is seeking Manufacturing specialist specializing in cell therapy (CAR-T) programs. This position is part of our Manufacturing facility. The manufacturing role serves as a Specialistin CAR-T production facility. You will work closely with our Research and Product Development teams to support the GMP Manufacturing operations, Technology transfer, quality assessments, and supply chain logistics and process validation of the CAR-T process across a wide range of novel modalities for Cell therapy programs. Role Responsibilities: As a Manufacturing specialist, a typical day might include the following: Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development/commercialization. Lead and train a team of cell process scientists/engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals. Manage and/or execute T-cell culture and differentiation to support process development, characterization, and validation. Manage troubleshooting with a high degree of complexity. Document experimental procedures and results according to established guidelines. Perform statistical analysis of experimental data to determine critical process parameter/result ranges. Support the development of SOPs and batch records, risk assessments as well as the technology transfers. Review completed production batch records and assist with deviations, CAPAs, Change Controls, and investigations. Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions. Collaborate effectively within departmental teams, contribute to deliverables and drive development activities in a cross-functional environment, engage on team discussions to resolve issues, and support/lead projects with a fully integrated team to facilitate successful outcomes. Serve as an internal technical subject matter expert and support technology transfers, engineering, and PV batches. Coordinate resources and set priorities for own/team, contributing to the overall goals of the department. Generate and review technical reports, regulatory filings, source documents, patents and external publications, as applicable. Align with leadership to develop strategic roadmap on continuous medium optimization and phase-appropriate medium development and implementation. Manage the medium development team to ensure timely delivery of cell culture medium development and optimization projects. Empower and support junior team members to independently plan and design experiments. Continuously grow and encourage team members on scientific and critical thinking. Qualifications PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology or a relevant life-science discipline, with relevant 915 years of industry experience within Cell and gene therapy, biologics manufacturing/product development functions.

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5.0 - 8.0 years

5 - 8 Lacs

Hyderabad, Telangana, India

On-site

You will be responsible for end to end Formulation development of Inhalation including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective?Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology?transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization,?processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents?for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials?and ensure development studies are performed related to regulatory and internal system requirements. Qualifications Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalationdosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. BehavioralSkills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.

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10.0 - 15.0 years

10 - 15 Lacs

Hyderabad, Telangana, India

On-site

You will be responsible Analytical method development and validation of injectable, Inhalationsand Nasal products. You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field. You will be responsible to execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team. You will be responsible for analytical method development for drug products for various tests mentioned in the specification in order to analyse the product development batches for the prototype screening. You will be responsible for analytical method validation activities at the manufacturing sites providing method development reports to verify the validation parameters and ensure the execution of method validation as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing. You will be responsible for analytical method transfer to plant locations successfully in order to train the Quality Control (QC) team on the methods for the Exhibit and commercial batch analysis at plant. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualifications Educational qualification: Masters in Science/ Organic chemistry/ Pharmaceutical Sciences Minimum work experience: 10 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Inhalation, Nasal and Injectable Products. Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Understanding on Abbreviated New Drug Application (ANDA) filing requirements. Experience in Process Optimization (Manufacturing) and Technology Transfer. Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. BehavioralSkills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.

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2.0 - 6.0 years

2 - 6 Lacs

Hyderabad, Telangana, India

On-site

Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional teamtowardsto meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualifications M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years

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5.0 - 10.0 years

0 Lacs

maharashtra

On-site

As the Assistant General Manager for Nasal Spray Formulation Development in the Research & Development department at the R&D Center in Chinchwad, Pune, you will be responsible for leading the development of innovative nasal spray formulations. Your role will involve steering projects from concept to commercial scale-up, focusing on designing, developing, and optimizing nasal spray drug products to ensure regulatory compliance and meet quality standards. You will be leading a team of formulation scientists and collaborating with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Your key responsibilities will include: - Developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Preparing and reviewing literature search reports for drug substances and products, and designing product development strategies based on the findings. - Planning and guiding executives for development batches in the lab, ensuring compliance with SOPs. - Providing expert input into formulation and process studies to ensure product compliance with specifications. - Ensuring formulations and processes designed at R&D scale are capable of scale-up and technical transfer to GMP facilities. - Evaluating alternate vendors for packaging material selection and monitoring stability studies. - Preparing/reviewing Technology Transfer documents and coordinating with all stakeholders within the organization. - Following Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP) and participating in stability and validation batch manufacturing. - Preparing Product Development Reports for regulatory submission and drug product approval. You should possess the following qualifications and skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or a related field, with a specialization in drug delivery systems or formulation science preferred. - 8-10 years of hands-on experience in formulation development, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Strong technical expertise in nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience in project management, working with cross-functional teams, and managing regulatory requirements. - Proven leadership abilities, excellent communication skills, and strong problem-solving capabilities. This role will require you to be primarily based at the R&D center in Pune, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,

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8.0 - 10.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Job Title: Manager / Associate Manager New Product Launches (SCM) Department: Supply Chain Management Location: Bangalore Reports To: Head- New Product Launches Job Summary: We are seeking a highly experienced and dynamic professional to lead and manage New Product Launches within the SCM function of our pharmaceutical organization. The ideal candidate will have over 8 years of experience in supply chain operations, with a strong background in project management , and hold a PMP certification . This role is critical in ensuring seamless coordination across cross-functional teams to deliver successful product launches on time and within budget. Key Responsibilities: End-to-End Launch Management: Lead SCM activities for new product introductions from planning to execution, ensuring alignment with regulatory, manufacturing, and commercial timelines. Project Leadership: Drive cross-functional project teams using structured project management methodologies (PMP), ensuring milestones are met and risks are mitigated. Stakeholder Collaboration: Work closely with Regulatory Affairs, Manufacturing, Quality, Procurement, and Commercial teams to ensure launch readiness. Supply Chain Planning: Develop and execute supply chain strategies for new products including demand forecasting, inventory planning, and distribution setup. Risk Management: Identify potential supply chain risks and develop mitigation plans to ensure uninterrupted product availability. Performance Tracking: Monitor KPIs related to launch execution and supply chain performance; provide regular updates to senior leadership. Process Improvement: Continuously improve launch processes and tools to enhance efficiency and scalability. Project Leadership: Manage end-to-end project lifecycle for new product introductions, including site transfers, alternate vendor setups, and product development. Technology Transfer: Oversee technology transfer activities ensuring compliance with regulatory and customer requirements. Cross-Functional Coordination: Act as SPOC for SCM, QA, QC, RA, Production, and external customers to ensure timely and successful product launches. Excellent communication and stakeholder management. Strong analytical and problem-solving abilities. Experience in handling regulatory and customer audits. Quick learner with adaptability and organizational skills. Qualifications: Bachelors or Masters degree in Supply Chain, Engineering, Pharmacy, or related field. Minimum 8+ years of experience in pharmaceutical project management/ supply chain operations. Proven experience in managing new product launches . PMP certification is mandatory. Strong understanding of pharmaceutical regulatory requirements and GMP. Excellent communication, leadership, and stakeholder management skills. Proficiency in project management tools (MS Project, Smartsheet, etc.) and ERP systems (SAP preferred). Preferred Attributes: Experience in biologics or specialty pharmaceuticals. Exposure to global supply chain operations. Lean Six Sigma certification is a plus. Show more Show less

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4.0 - 8.0 years

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indore, madhya pradesh

On-site

This role requires you to be highly skilled in technology transfer of Injectable products to manufacturing plants, including scale-up activities and demonstrating technical capabilities. You will play a key role in ensuring accessibility to both current portfolio and pipeline products. Additionally, you will share responsibility for achieving targeted product execution goals within the department/organization. Your duties will involve documentation, evaluation, and monitoring of batches at the manufacturing site. Your responsibilities will include performing product transfer activities for sterile products as assigned by the Manager/Senior Manager/Designee. You will be involved in the execution and supervision of Trial, Engineering, Scale-up, and Submission/Exhibit batches. You will compile results from scale-up trials, scale-up batches, and submission batches, drawing meaningful conclusions from the data. Moreover, you will be tasked with preparing various technology transfer documents such as Product risk assessment, Hold time study protocol & report, Scale-up batch protocol & report, among others. Your daily tasks will also encompass initiating requests for the creation or extension of Material codes, as well as working with SAP, document compliance manager, and other relevant software for documentation purposes. It is essential that you strictly adhere to the standard operating procedures (SOP) applicable at all PAR formulation sites, ensuring workplace safety. Furthermore, you will be responsible for conducting literature searches on quality management and Regulatory Guidance, as required. Collaboration with cross-functional teams to ensure timely completion of assigned activities is a crucial aspect of this role. You will be expected to develop project plans outlining timelines and target completion dates. Your support in documentation for various investigations, deviations, incidents, Out Of Specifications (OOS), Out Of Trends (OOT), and non-conformances, as applicable to R&D, will be highly valued. Ideally, you should hold a Bachelor's or Master's degree in Pharmacy, with a minimum of 4-8 years of relevant experience. Your exposure and experience in technology transfer, Manufacturing Science and Technology (MSAT), Technical services, and production for regulated markets in injectable/sterile products will be beneficial. Proficiency in GMP documentation activities, FDA regulations, and guidelines is essential. Additionally, strong communication skills, critical thinking abilities, and a proactive, innovative approach to work are key attributes for success in this role.,

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5.0 - 9.0 years

0 Lacs

sonipat, haryana

On-site

The main objective of this role is to ensure quality compliance and oversight during the technology transfer of agrochemical processes from R&D to the pilot plant. Your responsibilities will include facilitating and monitoring the technology transfer, reviewing and verifying pilot batch protocols, ensuring documentation compliance, providing on-floor quality support, coordinating analytical method transfer, and conducting training on quality-related procedures. You will play a key role in overseeing the technology transfer of agrochemical or technical grade actives, reviewing pilot batch protocols, ensuring compliance with Good Laboratory Practices (GLP) and relevant norms, providing QC support during lab-scale trials, and ensuring adherence to quality and EHS guidelines. Additionally, you will coordinate with QC and R&D for analytical method validation and transfer, ensuring that test methods are validated per agrochemical standards. In terms of qualifications and experience, you should have a B.Sc / M.Sc in Chemistry, Agriculture, or a related field, or a B.Tech / M.Tech in Chemical Engineering. You should have at least 5 years of experience in QA/QC within agrochemical, chemical, or formulation pilot plant environments. A good understanding of agrochemical formulation processes, handling hazardous substances, and familiarity with Indian (CIB&RC) and global regulatory standards will be essential for this role.,

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5.0 - 9.0 years

0 Lacs

delhi

On-site

As a Technology Transfer and Application Specialist, your primary mission will be to ensure the successful transfer of manufacturing processes and testing technologies to the local plant. Your responsibilities will include overseeing the accurate implementation and optimization of these processes to enhance efficiency and product quality. In this role, you will also be required to engage in cross-cultural communication and collaboration to effectively manage cultural differences during the technology transfer process. Your ability to promote synergy between teams from different backgrounds will be crucial in achieving successful outcomes. Continuous Improvement and Innovation will be key focus areas of your responsibilities. You will drive initiatives to enhance production efficiency, reduce costs, and improve product quality continuously. Your innovative thinking and problem-solving skills will play a vital role in achieving these objectives. Additionally, you will be responsible for providing systematic technical training for technicians and employees in local factories. Your role will involve ensuring that the workforce is well-equipped with the necessary skills and knowledge to support manufacturing processes effectively. To be successful in this position, you should have at least 5 years of experience in the automotive electronics manufacturing industry, with a strong understanding of manufacturing and test processes. Project management experience in automotive electronics-related product development or manufacturing roles will be advantageous. Previous management experience as a discipline PL or equivalent in a vehicle manufacturer's supporting automotive electronics program will also be beneficial. If you are looking for a challenging role that offers opportunities to lead technology transfer initiatives, drive continuous improvement, and collaborate across diverse teams, this position could be the perfect fit for you. Join our team and be a part of our mission to excel in automotive electronics manufacturing.,

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5.0 - 9.0 years

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ahmedabad, gujarat

On-site

As a Senior Chemist in the Pharma Manufacturing Industry located in Vatva, Ahmedabad, your primary responsibility will be to utilize your M.Sc. in Organic Chemistry along with 5 to 8 years of experience in API/Intermediates manufacturing to contribute significantly to the organization. Your role will involve hands-on experience in synthesizing APIs and intermediates, conducting literature searches using platforms such as SciFinder, Chemical Abstracts, Free Patent Online, and Journals. You will be responsible for feasibility studies, route selection for synthesis, multi-step synthesis, yield improvement, and cost reduction strategies. Additionally, you will be involved in extraction, purification, distillation, lab validations, process development, and ensuring strong documentation through technical reports, process safety reports, and cost sheets. A crucial part of your job will include technology transfer from lab to kilo lab and plant scale, requiring coordination with IPR, Regulatory Affairs, and QA departments. To excel in this role, you must possess knowledge of Chemdraw/Chemsketch and be proficient in coordinating with various departments. Please note that this position is open to male candidates only and individuals from the Pharma Manufacturing Industry. If you are passionate about driving innovation in API and intermediates manufacturing, and have a proven track record in process development and technology transfer, we encourage you to apply for this Full-time, Permanent position. For further details, please contact Himani (HR) at 9377165778. Apply now and be a part of our dynamic team where your expertise will be valued and your contributions will make a significant impact. ,

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0.0 years

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Paonta Sahib, Himachal Pradesh, India

On-site

Job description: We are looking for a skilled, innovative, and experienced food technologist to join our team as R&D Assistant Manager in Paonta Sahib. This pivotal role is centered on spearheading innovation in protein-based nutrition products, fostering cross-functional collaboration, and ensuring adherence to regulatory standards. The ideal candidate will have hands-on expertise in New Product Development (NPD) and Technology Transfer, with a strong focus on Nutraceuticals, Sports Nutrition, and Health Supplements. A deep understanding of formulation science, process innovation, and regulatory compliance is essential, along with a proven ability to transform scientific concepts into commercially viable products. We are seeking someone with a solid background in food technology, particularly in protein applications, and a demonstrated track record of successfully scaling products from concept to market launch. Key Responsibilities: Lead and manage New Product Development (NPD) projects for nutraceuticals including dietary supplements, functional foods, and health beverageswithin defined timelines. Develop innovative formulations across multiple dosage forms: tablets, capsules, powders, gummies, and liquids. Assess formulation feasibility and ensure strict compliance with FSSAI Nutraceutical Regulations, including adherence to ICMR RDA limits. Conduct lab-scale and pilot trials, ensuring seamless technology transfer to commercial manufacturing. Collaborate cross-functionally with teams in Quality Assurance, Regulatory Affairs, Marketing, and Production to drive product success. Optimize formulations for cost-effectiveness, process efficiency, and sensory appeal (flavor, color, texture). Select ingredients and define quantities based on validated scientific literature and clinical research. Maintain detailed technical documentation, including formulation records, trial reports, and stability data. Ensure regulatory compliance with FSSAI, AYUSH, and relevant international standards. Support manufacturing scale-up, troubleshooting production challenges and ensuring smooth execution. Conduct sensory evaluations and shelf-life studies to validate product quality and consumer acceptance. Manage raw material portfolios, including sourcing alternatives and evaluating supplier options. Develop taste-masking strategies for bitter or unpalatable ingredients to enhance consumer experience. Perform literature reviews, excipient selection, and compatibility studies to support formulation design. Design and validate nutritional information, label claims, and process flow diagrams. Prepare and maintain comprehensive documentation, including trial reports, BOMs, stability studies, and regulatory submission data. Skills & Competencies: Strong technical knowledge and project management capabilities. Excellent analytical and problem-solving skills. Effective communication and interpersonal abilities. Fluent in English and Hindi. Certifications & Training: Six Sigma Yellow Belt Training in Food Safety and Quality Standards Show more Show less

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5.0 - 9.0 years

0 Lacs

maharashtra

On-site

The role involves planning and resource allocation for routine operations within the analytical development function. You will be responsible for ensuring timely analysis of finished products and raw materials for various projects. Your duties will include reviewing analytical data, raw data, daily usage logbooks, and lab notebooks to support operations. You will also be involved in preparing and reviewing critical documents such as Analytical Method validation protocols, reports, method transfer protocols, and Standard Operating Procedures (SOPs). Additionally, you will conduct literature searches and provide guidance on new method development. Another key aspect of the role is to review data for stability studies and ensure timely analysis of samples. You will need to identify resource needs and initiate procurement to prevent delays in project deliverables. Supporting product technology transfers and ensuring compliance with safety measures will also be part of your responsibilities. In terms of quality management, you will be required to raise change controls, ensure data integrity, and adhere to Good Manufacturing Practices (GMP). You will also handle documentation related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and Occupational Health & Safety Assessment standards. As part of your job authority, you will review analytical data, plan and allocate resources, prepare and review SOPs, and technology transfer documents. You will also review calibration data, logbooks, and lab notebooks, as well as identify and report any near misses, hazards, or unsafe conditions. Other responsibilities include implementing QEHS policies and objectives, ensuring the use of personal protective equipment (PPE) during operations, and managing incidents and non-conformities effectively. You will also oversee work permit systems during maintenance activities and ensure proper waste disposal procedures are followed.,

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