Department Details
Role Summary
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. The candidate should understand concepts of downstream and upstream so that he/she can relate the conclusions with the changes made in the upstream or downstream processes. JOB DESCRIPTION ROLES & RESPONSIBILITIES (List in 'order of importance / time spent' as a '%' ) Responsibility Area Activities- % Time spend List of activities performed within each responsibility area Technical Design studies for the development of drug products for conducting various types of stability studies including process characterization studies 40 Technical Handling of instrument calibration/maintenance issues, interfacing with Engineering and vendors for instrument maintenance so that lab is functioning smoothly Technical Interpretation (including statistics) of data generated, preparing presentations for project meetings and presenting data to seniors Technical Enable process development activities including filter validation, extractables and leachables Documentation Data analysis and understanding trends in data generated, report writing and review, authoring sections for regulatory submissions, risk assessments 10 Cross-functional support Extensive involvement in tech transfer activities to manufacturing/partners/CROs and following the performance of the manufacturing process, including troubleshooting 20 Non-technical 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 10 Non-technical Ability to manage a team 20 COMPETENCIES The candidate should be able to have assertive and yet consensus building type of communication skills.
Key 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
Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 10 - 17 years
