Job Responsibilities

Formulation Manufacturing:
• Having full exposure on Formulation, Filtration and Filling GMP activities in scale-up and clinical batches.
• Media fill Process simulation/Aseptic Process Simulation for Drug Product.
• Involved in writing and review of Media fill and DP Batch Manufacturing Records.

Formulation Research and Development:
• To search for literature through research articles, review articles and patents for formulation procedures and composition establishment for bio-similar/Large Molecules products.
• Source and Characterization of Reference Listed Drugs (RLD’s).
• To perform experiments for selection and technical evaluation of raw materials and packing materials in formulation development.
• To perform formulation trials during optimization of process.
• To contribute to drug product development and technology transfer of formulation process and analytical methods from R&D to manufacturing site.
• To carry out the Photostability study for Drug substances and Drug product.
• To perform the compatibility studies for Drug Product.
• To perform Forced Degradation studies for Drug substance and Drug product for Impurity Profiling and Degradation pathway determination.
• To follow good documentation practices and good laboratory practices during development work.
• To write departmental SOPs, technical reports, study protocols as per developmental needs.
• To initiate stability testing (long term/accelerated/stress) of new products, drug substances and review/report results.
• To review and interpret analytical data for formulation studies.
• To perform HPLC analysis of ongoing formulation trails.
• Familiar with latest regulatory guideline – USFDA, EMA, ICH, PICS and PDA.

Job Requirements

• Min. bachelor’s degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Technology, or other equivalent background.
• Required skill: Communication skill (both verbal and written), computer literacy.
• Minimum 2-3 years of working experience preferably in Pharmaceutical/Biopharmaceutical Industry.
• Analytical knowledge and hand-on experience in at least one of the following equipment: HPLC, GC-FID, ICP-OES and Karl Fischer Titrator.
• Excellent analytical, multitasking.
• Ability to work independently and under pressure.
• Knowledge in cGMP/GLP procedures & work experience in the related field will be an added advantage