5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

As an R&D Executive at VTC R&D, you are responsible for performing and overseeing all activities related to formulation and filling process development. Your duties include having a strong understanding of optimizing vaccine formulations, selecting stabilizers and excipients, as well as preparing adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, and LNP formulation. You will also be involved in aseptic filling and Lyophilization cycle designing for new vaccine products and troubleshooting existing vaccines. In this role, you will execute clinical drug product manufacturing for clinical batches, plan and carry out media fill activities, and maintain R&D lab documents, equipment, and area qualifications in compliance with GMP requirements. Additionally, you will be responsible for preparing process validation and technology transfer protocols as per GMP requirements and collaborating with QA, QC, and Engineering departments for viral vaccine development activities. Ensuring proper hygiene and entry exit procedures in the formulation and filling section, preparing adjuvants, buffer solutions, and other materials, as well as coordinating with the central warehouse department for materials receipt and entry are also part of your responsibilities. You will supervise the preparation of disinfectant solutions, cleaning solutions, integrity testing of filters, and sanitization and disinfection activities in the R&D formulation department. As part of the QMS, you will handle deviations, MDD, investigations, observations, and ensure their timely closure. You will be involved in preparing standard operating procedures, batch manufacturing records, QRM, and protocols related to the R&D formulation and filling section. Moreover, you will supervise the washing, drying, packing, and sterilization of materials required for R&D development and GMP clinical batch preparation. Your role as an R&D Executive will be crucial in advancing vaccine development and ensuring compliance with quality standards and procedures.,

Posted 2 days ago

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Formulation Scientist for Vaccine R&D Zydus Group

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for performing and documenting all activities related to the formulation and filling process development. Your role will involve optimizing different vaccine formulations, selecting stabilizers and excipients, as well as preparing adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, LNP formulation, aseptic filling, and Lyophilization cycle designing for new vaccine products. Additionally, you will troubleshoot existing vaccines as needed. You will execute the clinical drug product manufacturing for clinical batches, plan and carry out media fill activities, and maintain R&D lab documents, equipment, and area qualifications in compliance with GMP requirements. Furthermore, you will be responsible for preparing process validation and technology transfer protocols as per GMP requirements and collaborate with QA, QC, and Engineering departments for viral vaccine development activities. Ensuring proper hygiene and entry/exit procedures in the formulation and filling section will be part of your responsibilities. You will also prepare adjuvants, buffer solutions, and other materials, and coordinate with the central warehouse department for the receipt and entry of raw materials and packaging materials. Supervision of disinfectant solutions, cleaning solutions, integrity testing of filters, and sanitization activities in the R&D formulation department will also be under your purview. Managing QMS processes such as deviations, MDD, investigations, observations, and ensuring timely closure will be crucial. You will also be involved in preparing standard operating procedures, batch manufacturing records, QRM, and protocols related to the R&D formulation and filling section. In addition, you will oversee the washing, drying, packing, and sterilization of materials required for R&D development and GMP clinical batch preparation. Preferred Candidate Profile: - Ph.D./M.Sc. in science (Biotechnology, Biochemistry, and Microbiology) or Masters Degree in Pharmacy or Engineering with biotechnology. - Experience in the vaccine industry. - Ability to work at the bench level, and this position involves one reporting relationship.,

Posted 3 days ago

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