WALK-IN Interview @PUNE- Drug Production/Drug Filling/Quality Control

Role & responsibilities

Quality Control

• Biochemical techniques: Protein estimation, Polysaccharide estimation, Titration, Nucleic Acid, Unreacted Functional Groups, EDC using UV visible spectrophotometer,
• Chromatography techniques: Ion-exchange chromatography, Gel-permeation (SEC) chromatography, Reverse-phase, HPLC and Gas chromatography.
• Electrophoresis techniques: SDS-PAGE, Agarose electrophoresis, Western Blot.
• Immuno assay techniques: ELISA (enzyme-linked immunosorbent assay), Antigen antibody immuno-agglutination and flocculation testing
• Cell culture techniques: Mammalian Cell Culture, Primary Culture, Virus Titration, Identification of virus, Passaging and Cell Maintenance, Cell-Based Assays, Inverted Microscopy, Fluorescence Microscopy, Extraneous agents, Mycoplasma and Mycobacteria testing.
• Molecular techniques: PCR (Polymerase Chain Reaction), RT-PCR, Molecular (Gene) Cloning.
• Analytical method validation (AMV), Analytical Method Development and Transfer Quality control (QC), cGMP, cGLP and QMS.

Drug Product (Filling-Staff/Operator)

• Experienced in handling of O-RABS.
• Operation of Vial washing/ Filling/Lyophilizers/Autoclave/Process vessels.
• Adhere the aseptic behaviour to maintain GMP systems.
• Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance.

Bacterial vaccine manufacturing

1. Drug substance Upstream:

• Experience in execution of upstream process operations such as seed germination, Fermenter operations, Harvest, Centrifugation, Process performance qualification and cleaning validation activities.
• Working under cGMP facility and regulatory audit exposure is an essential requirement.
• Must have an experience on Bacterial Toxoid vaccine manufacturing such as Typhoid, Tetanus, Diphtheria, Pertussis etc.
• Qualification: M.Sc. Biotechnology/Microbiology with 3-10 yrs. of experience at different levels.

2. Drug substance Downstream:

• Experience in execution of Downstream purification operations such as Cell lysis, Homogenization, TFF, Chromatography, Centrifugation, Sterile filtration, Process performance qualification and cleaning validation activities.
• Working under cGMP facility and regulatory audit exposure is an essential requirement.
• Must have an experience on Bacterial Toxoid vaccine manufacturing and its purification operations such as Hepatitis, Tetanus, Diphtheria, Pertussis etc.
• Qualification: M.Sc. Biotechnology/Microbiology with 3-10 yrs. of experience at different levels.

Vaccine Manufacturing (Cell Culture DS): -

• Responsible for cell revival, subculture, cell counting of MRC-5 cells.
• Preparation of MCB/WCB. Experience in Preparation of media and in process buffers in media mixing vessels.
• Experience in handling Roller bottles, Cell stacks, TCFs.
• Experience in working in GMP conditions / production department of viral vaccines.
• Preparation of SOP, BMRs, Protocols related to cell culture / virus culture.
• Experience in virus infection, virus harvesting procedures.
• Experience in working with Chicken embryo fibroblast cells, pooling of embryos, seeding of RBs.

Preparation of Media, in process solutions using preparation vessels

Preferred candidate profile

Education: - Post-Graduate in Biochemistry, Biotechnology, Microbiology, Life sciences, Pharmacy. M. Sc., M-Tech, M. Pharm (Pharm. Biotechnology) etc.