R&D Biologics Formulation Lead

Role & responsibilities:

• The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability
• The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus
• The candidate should have experience in running stability programs which include temperature, forced degradation studies, photo-stability studies etc. for multiple programs and should have demonstrated ability to trouble-shoot and course-correct as required in the development phase of Biosimilar drugs
• The candidate should have expert knowledge on product quality estimation techniques such as HPLC, CE-SDS etc that are connected to Drug Product development so that he/she should be able to understand the nuances of the data generated and relate it to the conclusions being made in formulation
• The candidate should have knowledge of particle characterization techniques such as DLS and should have experience in implementing such characterization techniques to drug product development.
• The candidate should have demonstrated experience in conducting studies for scale down model qualification and process characterization experiments associated with drug product. The candidate should be well-versed in basic statistics and should have experience in using statistical software such as JMP, Minitab etc.
• The candidate should have basic knowledge of regulatory guidance from USFDA, EMA etc. and should have knowledge of ensuring development is done to meet the regulatory requirement.
• The candidate should have years of experience in developing drug product related data for Biosimilars. The candidate should have mid-level knowledge of various container closure systems such as vials, pre-filled syringes, auto-injectors etc. that are prevalent in the market.

Preferred candidate profile:

• Design studies for the development of drug products for conducting various types of stability studies including process characterization studies
• Handling of instrument calibration/maintenance issues, interfacing with Engineering and vendors for instrument maintenance so that lab is functioning smoothly
• Interpretation (including statistics) of data generated, preparing presentations for project meetings and presenting data to seniors
• Enable process development activities including filter validation, extractables and leachables
• Involvement in vendor selection, evaluation, legal and IPR documentation, EHS activities and any ad-hoc trainings as required by the Company; discussions with external consultants
• Ability to manage a team

Educational Requirements:

• Masters in Biotechnology/Pharmacy/any other related field with 12 to 17 years of relevant industrial experience
• PhD in Biotechnology/Pharmacy/any other related field with 8 to 12 years of relevant industrial experience
• Post-doctoral research in relevant field with 2 to 3 years of relevant industrial experience