Manager Vaccine Formulation and R & D

Role & responsibilities

• To perform and be responsible for all the activities and documentation of formulation and filling process development and should have strong knowledge of optimization of different vaccine formulations, stabilizer selection, excipient selection, selection and preparation of adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, LNP formulation and preparation, aseptic filling and Lyophilization cycle designing for new vaccine products and troubleshooting for existing vaccines.
• To perform all the activities and documentation of the formulation and filling process, development and execution of clinical drug product manufacturing for the clinical batches, planning and execution of media fill activities
• Prepare and Maintain R/D lab documents, equipment and area qualifications as per GMP requirements and Responsible for preparation of process validation and technology transfer protocols as per GMP requirements and co-ordinates with QA, QC, Engineering department for viral vaccine development activities.
• Responsible to ensuring proper hygiene and entry exit procedures in the respective formulation and filling section and preparation of adjuvant, buffer solutions and other materials & ensuring proper arrangements for their preparation and supply. To coordinate with the central warehouse department for receipt and entry of RM and PM materials. Preparation / supervision of disinfectant solution, cleaning solution, integrity testing of hydrophobic and hydrophilic filters, sanitization and disinfection activities of R/D formulation department.
• Responsible for QMS such as deviations, MDD, investigation, observation and ensuring its timely closure. Preparation of standard operating procedure and Batch manufacturing records, QRM and protocol related to R/D formulation and filling section.
• To supervise washing, drying, packing and sterilizations of materials required for R/D development and GMP clinical batch preparation.

Preferred candidate profile

• PhD/MSc in science (Biotechnology, Biochemistry and Microbiology), masters degree in pharmacy or engineering with biotechnology.
• Candidate should have experience in vaccine industry
• Candidate should be able to work on bench and this position has one reporting.