606 Formulation Development Jobs - Page 7

Role & responsibilities Conduct formulation trials for solid, liquid, and semisolid dosage forms . Perform literature search and prepare survey reports. Execute design trials, sample batches, and submit for analysis. Prepare stability study batches and maintain related reports. Support scale-up, initial commercial batches, and process validation . Draft and review Technology Transfer Documents and product development reports. Ensure GLP & GMP compliance with laboratory safety standards. Prepare departmental SOPs and stage-wise development reports

Job Description: Formulation Development candidate - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop OSD formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets. Optimize drug release profiles to enhance therapeutic efficacy and patient compliance. Process Development: Develop scalable and robust manufacturing processes for oral solid dosage forms. Perform critical parameter optimization for processes like granulation, blending, compression, and coating. Analytical and Stability Studies: Collaborate with the analytical team to develop and validate testing methods for NDDS products. Conduct stability studies in compliance with ICH guidelines. Regulatory Compliance and Documentation: Prepare technical reports, protocols, and batch manufacturing records. Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development. Technology Transfer: Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing. Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer. Innovation and Research: Stay updated with emerging trends in NDDS and oral solid dosage technologies. Contribute to patent applications and publications to support organizational innovation initiatives. Key Requirements: M. Pharm / M.S. in Pharmaceutics or related field. 5 to 10 years of relevant experience in formulation development of OSD for USFDA or other regulated markets. Strong knowledge of QbD, scale-up and technology transfer. Experience in developing formulations for bioequivalence studies and regulatory submissions. Familiarity with USFDA/EMEA regulatory guidelines and documentation. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Hands-on experience with granulation, compression, coating, and capsule filling equipment. Ability to work cross-functionally in a fast-paced, deadline-driven environment.

Responsibilities: * Conduct market research & analyze trends * Develop new products through formulation & testing * Collaborate with cross-functional teams on product launches Annual bonus

M pharma if they have 5 years of experience or more or Ph.D. and less than 3-5 years of experience in nanoparticles, specifically lipid nanoparticles, nano emulsion,Pharma R&D Office cab/shuttle Health insurance Provident fund Annual bonus

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services 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! Additional Responsibilities: Ability to work with clients to identify business challenges and contribute to client deliverables by refining, analyzing, and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Technical and Professional Requirements: Primary skills:Technology->Java->Java - ALL Preferred Skills: Technology->Java->Java - ALL

Educational Requirements Master Of Comp. Applications,Master Of Engineering,Master Of Science,Master Of Technology,Bachelor Of Comp. Applications,Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology Service Line Engineering Services 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! Additional Responsibilities: Ability to work with clients to identify business challenges and contribute to client deliverables by refining, analyzing, and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Technical and Professional Requirements: Primary skills:Technology->IOT Platform->AWS IOT Preferred Skills: Technology->IOT Platform->AWS IOT

Develop and optimize formulations for oral solids and liquids to meet quality, stability, and regulatory requirements. Conduct pre-formulation studies, compatibility studies, and excipient screening for both dosage forms.

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

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.,

As a Production Manager- Formulations & Development at Dev Staffing Solutions in Raipur CG, your primary responsibility will be to oversee the day-to-day operations of formulation development. You will be tasked with managing production schedules, ensuring product quality, and maintaining compliance with regulatory standards within the pharmaceutical industry. To excel in this role, you should possess experience in formulation development and production management. A strong understanding of regulatory standards in the pharmaceutical sector is essential. Your leadership and management skills will play a crucial role in successfully fulfilling your duties. As a successful candidate, you will demonstrate excellent problem-solving and decision-making abilities. Prior experience with quality control and assurance processes will be advantageous in executing your responsibilities effectively. Ideally, you should hold a Bachelor's degree in Pharmacy, Chemistry, or a related field to qualify for this full-time on-site position at Dev Staffing Solutions. Join us and contribute to our mission of delivering top-notch human resources services in the pharmaceutical industry based in Hyderabad, India.,

As an Intern in CMC (Formulation) at Ferring India FHPDC R&D, you will be part of the CMC (Formulation) department in Hyderabad for a duration of 12 months. Reporting to the Lead Scientist - CMC (Formulation), you will receive a stipend for your work. To qualify for this position, you should have a Masters degree in Pharmaceutical Sciences (Pharmaceutics) or a related discipline from a reputable institution. A strong academic background in pharmaceutics is essential, along with basic knowledge of formulation principles and analytical techniques. Familiarity with regulatory guidelines such as ICH, FDA, and EMA is advantageous. Proficiency in MS Office (Word, Excel, PowerPoint) and scientific writing, as well as excellent communication, organizational, and problem-solving skills, are required. Your role as a Formulation R&D Intern will involve supporting the development of pharmaceutical dosage forms through hands-on laboratory work, data analysis, and documentation. You will gain exposure to formulation science, regulatory requirements, and industrial practices in a dynamic and collaborative environment. Key responsibilities include assisting in the design and optimization of formulations for various dosage forms, conducting pre-formulation studies, participating in excipient selection, preparing lab-scale and pilot-scale batches, operating laboratory equipment, maintaining accurate documentation, ensuring compliance with Good Laboratory Practices (GLP), collaborating with other departments such as Analytical R&D, Quality Control, and Regulatory Affairs, and contributing to formulation strategy discussions. This internship offers a unique opportunity to enhance your skills and knowledge in the field of CMC (Formulation) while working in a supportive and innovative environment at Ferring India FHPDC R&D.,

Dear Candidate, We have urgent opening for "Manager Techno Commercial" for a leading distributor of Pharma Excipients company for Ahmedabad locations. We are looking for candidates from Formulation Development background. Job Description: - The primary responsibility will be to manage and grow sales of excipients, at new and existing customers and to expand and advance the pipeline projects. - The role will be home/office based in India and requires significant travel. - The Account Manager will report to the Director Business development. Responsibilities : - Manage an assigned territory for Marketing and sales - Manage and grow sales of excipients, APIs and drug delivery platforms at established accounts and distributors and develop business at new customers. - Expand and advance pipeline through close collaboration with R&D, business development, purchasing and operations in the Region Pharma industry. - Explore opportunities for Pharma Solutions projects at major pharma customers. - Support introduction of new products on territory as per launch plan from Marketing. - Develop strong relationships and deep contacts at all levels throughout customer organizations with a focus on technical and business development groups. This will be led in close collaboration with the Region Technical Development Manager. - Increase exposure and market leadership through seminars, technical conferences and participation in industry organizations in close coordination with Asia Pacific TDM (meetings, trade shows, seminars). - Negotiate pricing and contracts, track and report on industry trends, monitor competitor activities and market share, submit new product ideas and assist with resolving customer issues. - Complete, update and execute the annual territory plan covering key accounts, territory objectives, target accounts and strategies. Develop specific Global Account Plans as needed. - Submit the Monthly /annual territory sales budget and forecasts. - Attend trade shows, industry conferences and local pharma organizations to keep current with industry trends and identify new opportunities. - Enter call reports, contact information and market data in Excel. - Support the team with demand planning as needed. - Collaborate with Customer Service/S&OP to optimize customer satisfaction. Skill Set Requirements : - Degree in Pharmaceutical Science (Master of Pharmacy) Chemistry, , or related scientific discipline. - Technical Enough to understand Product positioning and Make first level presentations - Minimum 1-year experience in developing new business and selling APIs and ingredients to Pharmaceutical manufacturers. - Comfortable in technical/scientific aspects of pharmaceutical development. Knowledge of pharmaceutical Quality and Regulatory requirements. - Multilevel sales contacts at the top pharmaceutical accounts in territory. - Strong interpersonal and negotiating skills. Willing to make cold calls and seek out key decision makers. - Ability to gain the trust of customers by connecting their strategic needs with capabilities. - Extensive travel required - minimum 75% of the time. - Excellent verbal and written communication skills. - Strong organization and planning skills. - Analytical skills and ability to use market research to recommend pricing and prepare offers. - Team player - Experienced in working in a global organization and multicultural teams. Open minded, willing to listen and to share ideas generated internally and by customers. - Excellent follow-up skills. - Driven, self-motivated, results oriented individual with the ability to work under limited supervision. - Motivated by fast evolving environment and challenges Kindly forward the updated resume along with CTC Details on yogeeta@shauryahc.in Regards

You should have a good understanding of product development activities for various injectable dosage forms intended for the regulated market, including general injectable and onco products. Knowledge of ANDA and 505b2 product filing is essential. Familiarity with a wide range of dosage forms such as liquid solution, lyophilized, suspension, and emulsion is required. You should also be well-versed in drug device combination products and understand regulatory expectations. Experience with equipment like high shear homogenizer, high pressure homogenizer, lyophilizer, microfluidizer, and nano mill is preferred. Your responsibilities will include preparing and reviewing product development reports, master formula records (MFR), stability protocols, study protocols, and standard operating procedures (SOP). You should have a basic understanding of Quality by Design (QbD) principles for formulation development, including Quality Target Product Profile (QTTP), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Material Attributes (CMA), risk assessment, and control strategy. Knowledge of various Quality Management System (QMS) documents like change control, incidents, planned deviations, and unplanned deviations is necessary. A fundamental understanding of API specifications, Drug Master Files (DMF), excipient specifications, in-process specifications, finished product specifications, and shelf-life specifications of injectable products is expected. Additionally, you should be familiar with the preparation and review of necessary documents required for ANDA submission and product approval. Your skills and expertise should be at an advanced level in formulation development for solution-based injectables, while scale-up and process optimization, material science and excipients selection, CoA & analytical data review, and technical troubleshooting should be at an intermediate level. Regulatory affairs and compliance skills are expected to grow over time, along with cross-functional coordination, stability testing, protocol development and documentation, and cross-functional collaboration. Investigation & CAPA management is also at an intermediate level. Qualifications: - M Pharm Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team at Amneal plays a crucial role in partnering with all aspects of the organization to drive success through effective people management. They provide high-level input at a strategic level, ensure legal compliance and best practices, offer support and advice to meet organizational objectives, provide expert guidance on workforce management and employee relations, and keep the organization informed about developments impacting employment matters.,

As an Application Development Scientist at Momentive, you will collaborate with a diverse team to innovate new silicone/silane-based additives and resins for various markets such as architectural coatings, construction chemicals, protective coatings, and inks. Your role will involve utilizing your technical knowledge to develop innovative solutions, address customer needs, and establish strong customer relationships. Working closely with sales, technology, marketing, manufacturing, and product stewardship teams, you will contribute to the growth and success of the company. Your responsibilities will include understanding market trends, translating customer needs into product concepts, providing technical input for product design, supporting new product introductions, offering customer support, and creating promotional materials. You will also engage in customer training, relationship-building, market analysis, and collaboration on new business opportunities. Additionally, you will participate in calls, seminars, and webinars, and assist in product launches and competitive analysis. To qualify for this role, you should hold a B. Tech/M. Tech in Chemistry, Material Science, or Engineering, with a minimum of 5-7 years of experience in R&D, application development, technical sales, or formulation related to coatings. Proficiency in additive applications, interpersonal skills, and willingness to travel regionally and internationally are essential requirements for this position. Momentive offers a competitive total rewards package, development opportunities, and an inclusive culture that supports personal growth and career advancement. By joining the Momentive team, you will be part of a global company dedicated to creating sustainable solutions that positively impact various industries and aspects of life. If you are passionate about innovation and problem-solving, consider becoming a valuable member of our team and help shape a brighter future. Momentive is a leading global advanced materials company specializing in silicones and specialty products. Our extensive product portfolio contributes to advancements in diverse industries such as agriculture, automotive, aerospace, electronics, healthcare, consumer products, and construction. Through continuous innovation, Momentive strives to build a more sustainable future and make a meaningful difference in the world. Candidates interested in this position must apply for employment and meet the legal working age requirements as per local laws. Pre-employment conditions may apply, and all offers are subject to compliance with relevant laws and regulations. Please note that Momentive is not engaging with search and selection firms or employment agencies for assistance at this time.,

The role of Group Leader in Research Chemistry at PI involves leading a team of research scientists and team leaders to direct and supervise research activities for multiple projects focused on discovering and pre-developing innovative chemicals for crop protection and growth. The primary objective is to enhance the business value of PI through the development of novel solutions. As the Group Leader, you will collaborate closely with the Director of Discovery Chemistry to plan projects efficiently, manage resources effectively, drive knowledge management, foster innovation within teams, and generate new intellectual property through patents. Your responsibilities will include: - Demonstrating advanced knowledge of research processes and methods, such as designing research projects, conducting sampling, implementing controls, and analyzing results accurately. - Possessing strong clinical and laboratory skills, including a deep understanding of lab procedures, equipment, and protocols. - Exhibiting expert knowledge of molecular chemistry and chemical synthesis. - Proficiency in using MS Office applications and relevant computer programs for data analysis. - Demonstrating excellent project management skills, including planning, work allocation, and performance monitoring. - Mentoring the team to address technical queries related to research activities effectively. - Reviewing and approving research results to ensure the accuracy and validity of analysis and findings. - Monitoring the progress of research activities, providing guidance to team leaders on corrective actions when necessary. - Actively participating in knowledge management initiatives by contributing to the KM portal and encouraging team members to do the same. - Contributing to competitor intelligence through secondary research and engagement in internal/external forums and professional networks. - Identifying and implementing best practices in formulation development. - Representing the department at external forums as deemed appropriate. Requirements: - PhD in Organic Chemistry or Agro Chemistry from a reputable University or Institute with outstanding academic achievements. - Post-doctoral research experience in a prestigious university abroad, particularly in the US, Western Europe, or Japan. - Research publications and/or patents are highly valued. Qualifications: - 12-16 years of post-academic industrial research experience, with a minimum of 3-5 years in team management roles.,

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.,

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.,

As an R&D Technician, you will play a crucial role in the development of new formulations, materials, and processes while maintaining a strong focus on quality and compliance. Your responsibilities will include conducting laboratory trials, stability studies, and sample evaluations. Additionally, you will collaborate with QA/QC teams to ensure product consistency and reliability. Analyzing data from research experiments and quality assessments will be a key part of your role, providing valuable insights to inform product improvements. It will be essential to maintain accurate documentation for all R&D activities, including technical data sheets, specifications, and trial reports. Ensuring that all R&D activities align with ISO, GMP, HACCP, or other relevant quality standards is crucial. You will also be required to participate in internal audits, validations, and regulatory inspections as necessary. Providing technical support to production teams during scale-up and commercialization phases will be another important aspect of your role. In the event of quality-related issues, you will collaborate with production and quality control teams to investigate and resolve them effectively. Staying updated with industry trends, regulations, and new technologies will also be expected from you as part of this role. This is a full-time position based in Hajipur, Bihar. Relocation or reliable commuting to the workplace is preferred. The job requires in-person presence, and the application deadline is 18/08/2025, with an expected start date on the same day.,

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.,

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.,

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.

We are seeking a dynamic and experienced Specialist in Formulation Development team to develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification. Ensure successful development of robust stable formula and process for given product from bench scale to commercial level. Roles & Responsibilities You will be responsible to Review and analyse data, collaborating with the Strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization. You will be responsible to evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase. You will be responsible to strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the Analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product. You will be responsible to perform and review experiment documentation as per company systems (ELN). Write Batch plans, protocols, sampling plans etc. You will be responsible to ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development. You will be responsible to facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function. You will be responsible to provide guidance to develop formulation capabilities within team. Qualifications Educational qualification: Masters/Ph.D in pharma Minimum work experience: 7 years of experience in Formulation development Skills & attributes: Technical Skills Experience in end-to-end product development and troubleshooting. Developed Oral Solid dosage forms and delivered 3-4 products overall for regulated markets. Good theoretical and practical understanding of different stages of formulation research and development Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools. Basic understanding of engineering principles & process controls related to equipment and process scale ups. Knowledge of agency requirement like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs). Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects. BehavioralSkills Excellent communication and interpersonal skills. Business Acumen & Decision Making 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.

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.,

You will be responsible for conducting project-related experiments and documenting the findings. Your primary tasks will include following the standard operating procedures (SOP) at all PAR formulation sites, such as labs and production facilities, while ensuring laboratory safety. Additionally, you will be assigned formulation development projects by your HOD/Manager/Designee and will be responsible for conducting literature searches on APIs, patents, excipients, and technologies relevant to formulation development. Collaboration with cross-functional teams will also be required to ensure the timely completion of assigned activities. The ideal candidate for this position should have an M.Pharm degree with a minimum of 1 year of experience in Injectable product development.,

As the Laboratory Manager at Motley Exim Co., you will be responsible for overseeing day-to-day lab operations to ensure safety standards are met and procedures are followed. Your role will involve the maintenance of lab equipment and efficient management of inventory for smooth workflow. You will be in charge of inventory control, tracking and managing all laboratory supplies, raw materials, and resources to maintain adequate stock levels and reorder timely when necessary. Additionally, you will be involved in Formulation Development, creating new formulations that meet project specifications while adhering to quality, performance, and regulatory standards. Conducting thorough product testing will be a key aspect of your responsibilities, where you will test formulations for stability, performance, and compliance. Documenting and analyzing test results will be crucial to support product development and enhancement. Staying updated on industry trends, materials, and technologies will be essential for Research & Innovation purposes. You will be expected to identify opportunities for innovative solutions in product offerings and enhance the company's competitive edge. Collaboration with cross-functional teams, including production, quality assurance, and marketing, will be vital to ensure product alignment and successful implementation across departments. Motley Exim Co. is a renowned company specializing in designing, developing, and manufacturing high-quality camouflage products. The flagship brand, Campro, offers innovative solutions for concealment and deception.,