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3.0 - 7.0 years
0 Lacs
hyderabad, telangana
On-site
The Technology Transfer Associate is responsible for coordinating and executing the seamless transfer of pharmaceutical products to Ritsa manufacturing Facility from client /R&D or result in any merger or acquisition. This role will oversee the planning, execution, and completion of projects with end-to-end accountability for deliver in time This role ensures that all processes (analytical and manufacturing) are effectively transferred while maintaining compliance with regulatory requirements, quality standards, and operational efficiency. Key Responsibilities: Project Planning and Execution Define project scope, objectives, deliverables, and timelines. Develop detailed project plans, allocate resources, and manage budgets. Monitor project progress and ensure milestones are met within the set constraints. Technology Transfer Execution: Facilitate the transfer of manufacturing / analytical processes between transferring sites. Collaborate with cross-functional teams (R&D, QC, Quality, Regulatory, and Manufacturing) to ensure a smooth transition. Provide technical support during process scale-up, validation, and commercial launch. Process Documentation & Compliance: Prepare and review technology transfer documents, including Master Batch Records, Process Validation Protocols, and Reports. Ensure compliance with cGMP, regulatory guidelines, and company SOPs. Support the preparation of regulatory submissions related to process validation and manufacturing changes. Troubleshooting & Continuous Improvement: Identify and resolve technical challenges during process transfer. Analyse data and propose improvements to enhance efficiency, yield, and quality. Work with production teams to implement process optimizations. Risk Management: Identify potential risks and develop mitigation strategies. Address project roadblocks proactively to minimize delays or budget overruns. Process Improvement and Innovation: Evaluate and implement process optimization opportunities. Lead initiatives to improve manufacturing efficiency and product quality. Collaboration & Stakeholder Management: Liaise with external partners, vendors, and regulatory bodies as needed. Participate in cross-functional meetings and ensure project timelines are met. Qualifications & Experience: Education: B.Pharm / M.Pharm (Pharmaceutical Sciences) Experience: 3-6 years in technology transfer, process development, or manufacturing in a regulated pharmaceutical environment. Knowledge: Strong understanding of cGMP, ICH guidelines, and regulatory expectations. Experience with process validation, scale-up, and troubleshooting. Familiarity with solid oral dosage forms. Key Skills: Strong analytical and problem-solving abilities. Excellent documentation and technical writing skills. Effective communication and cross-functional collaboration. Ability to handle multiple projects with attention to detail.,
Posted 2 days ago
5.0 - 15.0 years
0 Lacs
hyderabad, telangana
On-site
As a Formulations Scientist located in Hyderabad, India, you will be responsible for developing oral solid dosage forms of both Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, and Formulation Design to ensure the development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Your responsibilities will involve being a mentor and motivator to your team. You will be tasked with developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. Additionally, you will evaluate patents, develop non-infringement strategies, and have the capability of developing Paragraph IV products. You will be required to oversee the scale-up and optimization of the manufacturing process, execute pre-exhibit and exhibit batches, and handle the technology transfer from R&D to production to meet project timelines. Your role will also involve planning and contributing to project-related scientific/technical activities, authoring technical documents for regulatory filings, and interacting with API manufacturers, CROs, and CMOs as necessary. Furthermore, you will work collaboratively with cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs, and protocols. You will be responsible for creating and reviewing SOPs, ensuring documentation and test results accuracy and compliance with SOPs/GMP requirements, and coordinating with Regulatory Affairs for ANDA filings and Supplements filing. To qualify for this position, you should hold a Masters degree with a minimum of 15 years of experience or a Ph.D. in Pharmacy with at least 5 years of relevant experience in oral solids product development within the generic pharmaceutical industry. Experience in Generic R&D and a successful track record of AND submissions are essential. Knowledge of modified release dosage forms is advantageous. Candidates should possess self-motivation, excellent written and verbal communication skills, as well as good interpersonal and project management skills.,
Posted 3 days ago
14.0 - 20.0 years
25 - 30 Lacs
hyderabad
Work from Office
Responsible for planning and executing seed production volumes, resource management, and ensuring high quality seed delivery through productivity enhancement and technology integration Oversees farmer/organizer coordination & safety compliances Required Candidate profile Education : M.Sc. Agriculture with 14 to 20 Years of experience Strong people manager with leadership qualities to motivate the team members and mentor
Posted 1 week ago
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.,
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
gujarat
On-site
You will be joining a leading innovation-driven organization in India, known for its advanced solutions in paints, adhesives, and construction chemicals. This company is currently enhancing its research and development capabilities and is in search of an experienced specialist to take charge of product development and scale-up initiatives. Your main responsibilities will include leading the research and development of water-based acrylic emulsions for various applications, designing and optimizing polymerization processes for new product formulations, overseeing the synthesis and scale-up of polymers for paints, adhesives, and construction chemicals, collaborating with cross-functional teams to transition lab-scale innovations to commercial production, conducting performance testing, benchmarking, and continuously improving product lines, as well as maintaining documentation, IP records, and ensuring regulatory compliance. To excel in this role, you should have deep expertise in water-based acrylic emulsion chemistry, a strong command over polymer synthesis, emulsion polymerization, and formulation science, proven experience in scaling up from lab to pilot and commercial scale, familiarity with application-specific requirements in paints, adhesives, and construction chemicals, an analytical mindset with practical experience in characterization techniques such as DSC, TGA, FTIR, Rheology, and the ability to work independently and mentor junior researchers. This position is based in Jhagadia, Gujarat, offering a strategic advantage with access to state-of-the-art manufacturing facilities and R&D infrastructure.,
Posted 2 weeks ago
4.0 - 8.0 years
0 Lacs
ahmedabad, gujarat
On-site
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.,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
vadodara, gujarat
On-site
You will be responsible for managing a set of assigned research tasks in the field of Research & Development, including benchmarking targets, compiling research data, and ensuring regulatory compliances such as ISO, NABL, and Internal Management System. Your role will involve managing and executing lab and scale-up activities for research and development, including synthesis, analytical testing, formulation, and product development. It will be crucial for you to ensure the reproducibility of experimental data, organize facilities for experiments, and work on method development for timely task resolution. Additionally, you will be expected to create SOPs for lab and scale-up experiments, review and validate experiments and methodologies, and ensure the achievement of set milestones for lab/scale-up studies. As a Senior Research Scientist specializing in inorganic chemicals in Vadodara, your job responsibilities will include conceptualizing, planning, executing, and completing experiments in specialty inorganic chemical synthesis. You will supervise and conduct experiments in the domain of specialty inorganic chemicals, perform testing and evaluation of processes using bench-scale and pilot-scale units, and generate high-quality experimental data. Furthermore, you will be responsible for conducting literature surveys, developing standardized work methods, ensuring compliance with safety standards, preparing internal technical reports, and participating in scale-up activities, plant trials, and commercialization processes. To excel in this role, you are required to have a Ph.D. in Chemistry with a specialization in inorganic chemistry and a minimum of 3-5 years of research experience in the relevant area. You should possess in-depth knowledge and expertise in inorganic material synthesis and chemistry, with specific knowledge of antimony chemistry being preferred. Hands-on experience in inorganic material synthesis, analytical characterization techniques, process evaluation, and scale-up is essential. Moreover, familiarity with relevant guidelines, codes, standards, and regulations applicable to the research domain is required. You are expected to remain updated on the assigned task and related work being pursued elsewhere by conducting literature surveys, possess knowledge on relevant technologies, engage in external liaising, participate in commercial trials to understand product requirements, and identify the need for facility upgradation and procurement of infrastructures. Compliance with internal technical management systems, enforcement of applicable HSE procedures/practices, and adherence to regulations related to environment, safety, and IP are key aspects of this role. Additionally, you should have sound knowledge in the execution and management of the specific field.,
Posted 3 weeks ago
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.,
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
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.,
Posted 1 month ago
15.0 - 20.0 years
0 Lacs
maharashtra
On-site
The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,
Posted 1 month ago
5.0 - 10.0 years
0 Lacs
maharashtra
On-site
The Assistant General Manager - Nasal Spray Formulation Development will play a crucial role in leading the development of innovative nasal spray formulations within the Research & Development (R&D) department of a Pharmaceuticals company. Reporting to the Head of R&D, you will be responsible for driving projects from concept to commercial scale-up, ensuring regulatory compliance and meeting quality standards. Your primary focus will be on designing, developing, and optimizing nasal spray drug products for global markets. Key Responsibilities: - Develop and technology transfer Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Conduct literature search reports for drug substances and products, design product development strategies, and propose different formulation strategies based on the review outcomes. - Guide executives in lab development batches, provide expert input into formulation and process studies, and ensure compliance with specifications. - Evaluate packaging material vendors, monitor stability studies, and prepare/review Technology Transfer documents. - Coordinate with internal stakeholders, follow GLP & GMP, participate in stability and validation batch manufacturing, and prepare PDR for regulatory submission. Qualifications & Skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field. - Specialization in drug delivery systems or formulation science preferred. Experience: - 8-10 years of formulation development experience, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Proven experience in nasal spray product development from early-stage to commercial scale-up. Technical Expertise: - Strong understanding of nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience with device development and knowledge of regulatory requirements for nasal spray formulations. Project Management: - Strong project management skills, ability to manage multiple projects, work with cross-functional teams, and deliver results. Regulatory Knowledge: - Experience in preparing and reviewing regulatory submissions, familiarity with CMC requirements for nasal formulations. Leadership & Communication: - Ability to lead and develop a team, excellent communication and presentation skills for conveying complex scientific information. Problem-Solving & Innovation: - Strong analytical and problem-solving skills, ability to innovate and apply new technologies to improve drug delivery processes. Work Environment: - Primarily based at the R&D center with occasional travel to manufacturing sites, vendors, and regulatory meetings. Join us in this exciting role to contribute towards developing high-quality nasal spray formulations for global markets.,
Posted 1 month ago
10.0 - 16.0 years
0 Lacs
karnataka
On-site
Seeking a skilled professional with 10-16 years of experience in Protein/Peptide Purification to lead and oversee a team. The ideal candidate will excel in purification techniques, leadership, experiment planning, data analysis, mentoring, troubleshooting, scale-up, and cost improvement. As the Peptide Purification Lead at the managerial level, you will be responsible for leading daily operations in the peptide purification lab, managing workflows from milligram to gram scale. Your role will involve supervising and mentoring a team, assigning tasks, troubleshooting, and fostering skill development. You will be expected to analyze experimental data such as chromatographic profiles, purity, and yield, and generate technical reports. Additionally, you will manage laboratory budgeting and costing for purification activities, plan and schedule purification experiments, and be involved in downstream process development and scale-up activities related to peptide/protein purification. To be successful in this role, you must possess in-depth knowledge of peptide chemistry and purification methods, as well as a good understanding of downstream processing and the unit operations involved in peptide/protein purification. You should have experience in using statistical tools for Design of Experiments (DoE) and Quality by Design (QbD) in the process development of peptides/proteins. Utilizing analytical thinking and data interpretation skills will be key to your success, along with familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory standards. The qualifications and experience required for this position include an M. Tech or PhD in Chemistry, Biochemistry, or a related field, along with 10-16 years of experience in a Protein/Peptide Purification role. If you meet these criteria and are interested in this opportunity, please send your CV to rashmi.gupta@biocon.com. In your CV, please include your experience in Peptide Purification and the total number of years you have worked in this field, your current Cost to Company (CTC), Notice Period, and Qualifications. Please note that this is an onsite job located in Bangalore, requiring your presence five days a week.,
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
halol, gujarat
On-site
As an Executive in MSTG at Sun Pharmaceutical Industries Ltd, your primary responsibility involves executing technology transfers to Sun/CMO sites, overseeing scale-up processes, exhibit batches planning, and process validation. This requires effective planning and efficient utilization of resources such as manpower, materials, and machinery. You will be responsible for various documentation tasks including the preparation of new production introduction forms, scale-up reports, reviewing Sun/CMO Batch Manufacturing Records (BMR), developing sampling plans, process validation (PV) protocols, User Requirement Specification (URS) preparation, and Dashboard preparation. It is essential to ensure that products are manufactured and stored in compliance with relevant documentation to achieve the desired quality standards. Additionally, your role includes reviewing and providing comments on Master Formulae (MF), Failure Mode and Effects Analysis (FMEA), Risk Assessments (RA), and protocols such as Sampling plans and Process Validation protocols to ensure regulatory compliance. You will also be involved in handling and supporting troubleshooting batches for data comparison and root cause investigation at Sun/CMO sites, investigating product troubleshooting, and overseeing timely packing operations. Furthermore, you are required to monitor and conduct pre-checks on equipment planned for use in scale-up, exhibit, and process validation batches, including equipment preparation, vial washing and dehydrogenation, Clean-in-Place/Sterilize-in-Place (CIP/SIP) systems, Programmable Logic Controllers (PLCs), and various instruments. Your role also involves supervising and conducting skid trials to enhance product development, improve processes, and address potential manufacturing constraints effectively.,
Posted 1 month ago
10.0 - 14.0 years
0 Lacs
haryana
On-site
As a Technical and Scientific Leader in upstream processes for early-stage development, you will play a crucial role in ensuring the seamless handover of Suns Branded Portfolio products from development to commercialization. Your responsibilities will include providing quality input into CMC strategy, representing quality oversight in various stages of process development, and contributing to the planning of Clinical trial materials. You will also collaborate with cross-functional teams to facilitate a smooth transition to Commercial QA and manufacturing. Your scientific leadership will be instrumental in supporting process and product investigations, troubleshooting issues, and identifying opportunities for improvement. You will be expected to leverage your technical expertise to oversee experimental planning, analyze development results, and review manufacturing data. Additionally, you will be responsible for authoring and reviewing CMC documentation for regulatory filings, as well as providing support during health agency inspections. In order to excel in this role, you must possess an MS or PhD in chemical/biochemical engineering, biochemistry, or a related field, along with a minimum of 10 years of relevant experience. A proven track record of technical manufacturing experience, the ability to drive technical quality rigor, and strategic analysis skills are essential. Your capacity to manage multiple projects in a fast-paced environment, utilize risk-based decision-making approaches, and work collaboratively in a matrix environment will be critical to your success. Furthermore, your strong interpersonal skills, effective communication abilities, and demonstrated project management capabilities will be valuable assets in this role. Experience with audits in global regions and the flexibility to travel to the US and/or EU countries will be advantageous. If you are looking to join a dynamic Development Quality team and contribute to the advancement of Suns Branded Portfolio products, this opportunity may be the perfect fit for you.,
Posted 1 month ago
5.0 - 10.0 years
0 Lacs
maharashtra
On-site
The Manager - Nasal Spray Formulation Development will lead the development of innovative nasal spray formulations, driving projects from concept to commercial scale-up. You will focus on the design, development, and optimization of nasal spray drug products, ensuring regulatory compliance and meeting quality standards. Leading a team of formulation scientists, you will collaborate with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Key responsibilities include having relevant experience in developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. You will be responsible for preparing and reviewing literature search reports for drug substances and products, proposing formulation strategies, guiding executives for development batches in the lab, providing expert input into formulation and process studies, and ensuring compliance with specifications. Additionally, you will evaluate vendors for packaging material, monitor stability studies, prepare Technology Transfer documents, coordinate with stakeholders, and adhere to GLP and GMP. Qualifications and Skills required for this role include an M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field with specialization in drug delivery systems or formulation science preferred. You should have 8-10 years of hands-on experience in formulation development, with at least 5 years focused on nasal spray or inhalation formulations. Technical expertise in nasal spray formulation techniques, drug-excipient interactions, device development, particle size distribution, viscosity, and droplet characteristics is essential. You should possess strong project management skills, experience in working with cross-functional teams, and knowledge of regulatory requirements for nasal spray formulations. Leadership qualities, excellent communication and presentation skills, problem-solving abilities, and a knack for innovation are crucial for this role. The work environment will primarily be based at the R&D center, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
gujarat
On-site
As a Formulation and Development Officer for our client based in Vatva, Gujarat, you will be responsible for various key tasks. Your primary duty will involve the development of formulations for all dosage forms such as tablets, capsules, ointments, creams, gels, oral liquids, injectables, and novel drug delivery systems for different markets including regulated, domestic, and ROW markets. This includes activities like document review, planning, and conducting stability studies of R&D batches. Additionally, you will be required to provide technical support for the scale-up and technology transfer to manufacturing processes. You will play a crucial role in troubleshooting formulation-related issues that may arise during production, ensuring a smooth manufacturing process. To qualify for this position, you should hold a Bachelors or Masters degree in Pharmacy. If you believe you possess the necessary qualifications and skills for this role, we encourage you to share your updated CV with us. We look forward to reviewing your application and will reach out to you promptly.,
Posted 1 month ago
14.0 - 18.0 years
0 Lacs
uttar pradesh
On-site
As the leading international supplier of active pharmaceutical ingredients (APIs), we at TAPI take pride in our extensive portfolio of over 350 API products and our reputation as a trusted partner for 80% of the top 50 global pharmaceutical companies. With a history dating back over 80 years, we have established ourselves as industry leaders through our experience, expertise, technologies, and exceptional customer service. Our success is driven by our dedicated team of over 4,000 professionals spread across 14 sites worldwide, with state-of-the-art production facilities in multiple countries. We are committed to continuous innovation and investment in research and development to ensure a steady flow of high-quality APIs and the timely introduction of new products to the market. In this role, you will be responsible for various aspects of product transfer, scale-up, proposals, Capex evaluations, and process engineering calculations. Your key tasks will include improving the yield, efficiency, and cost effectiveness of developed APIs by introducing new technologies, troubleshooting plant-related problems, and contributing novel ideas during technical discussions. Additionally, you will be involved in cycle time reduction, capacity enhancement, and coaching and developing a team of engineers to drive performance and engagement. The ideal candidate will have a solid background in API manufacturing, with a deep understanding of scale-up processes and experience in handling CDMO products. You should possess expertise in chemical process unit operations, Quality by Design, process safety, technology transfer, and commercial production. Strong communication, project management, and supervisory skills are essential for collaborating effectively with internal teams and external stakeholders. To qualify for this role, you should hold a B.Tech/M.Tech in Chemical Engineering from a reputable institute and have 14-16 years of experience in the field, including at least 5 years in people management. Your ability to handle multiple projects simultaneously, troubleshoot issues, and use process modelling tools will be critical for success in this position. If you are a proactive, detail-oriented professional with a can-do attitude and a passion for driving excellence in API manufacturing, we invite you to join our team at TAPI and play a key role in our mission to deliver high-quality pharmaceutical ingredients to the global market. This position reports to the Associate Director, MS&T.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a Process Engineer at Syngene International Limited in Mangalore, you will play a crucial role in contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the company's integrity and quality standards. You will be responsible for driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline at the workplace. Your primary focus will be on ensuring all safety precautions are followed and adhering to EHSS policies. Your educational background should include a BE in Chemical Engineering, and you should have a minimum of 2 to 3 years of experience as a Process Engineer with Pharma experience. You will be involved in activities such as scale-up, reactor mapping, QMS, EHSS, and more. It is essential that you comply with Syngene's quality standards at all times and ensure operations are carried out in accordance with current Good Manufacturing Practices, Good Documentation Practices, and Data Integrity policy. Your responsibilities will include evaluating the process with respect to critical chemicals, volumes, and process conditions, mapping the process in the MSEZ facility, preparing batch sizes and calculating capacity, and determining operating costs for the mapped product. You will also be involved in preparing a list of modifications/facilities required in the production facility, coordinating with the CFT to plan and execute these modifications/facilities, and supporting the Production team for scale-up and execution of initial batches and validation. Additionally, you will work on process improvement in running products, contribute to improvements in utilities and energy management, attend training on standard operating procedures, and maintain good health and hygiene practices. Your behavioral skills should include adhering to company systems and policies with dedication to work, having a result-oriented approach, being self-driven, and possessing strong team coordination skills. Syngene International Ltd. is an equal opportunity employer, and as a Process Engineer, you will have the opportunity to be part of an innovative culture driven by a passionate team of scientists. If you are a detail-oriented individual with a strong background in chemical engineering and a passion for process improvement, this role may be the perfect fit for you.,
Posted 1 month ago
1.0 - 6.0 years
4 - 8 Lacs
bengaluru
Work from Office
R&D trial batch execution & documentation Good knowledge on solid oral/Liquid oral dosage form
Posted Date not available
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