Scientist- Downstream Process & Formulation development

Job Description

Department: R&D Biotech (Downstream Process) at Airoli, Navi Mumbai Role: Downstream Process & Formulation development Opportunity: This role provides an opportunity to learn and grow to an advance level of expert in the field of downstream processing & formulation development of Recombinant Biotherapeutics Proteins. Role & responsibilities Development of non-infringing downstream purification process for cell culture based biotherapeutic proteins towards submission in India & various regulated countries. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Responsible for end-to-end process optimization of all purification unit operations viz. chromatography (Affinity, IEX, HIC, etc.), UF/DF TFF, Nanofiltration, etc. towards optimization of overall DSP process. Should carry out troubleshooting in least possible time. Fine execution of day-to-day purification works at lab and active, productive coordination with cell culture and analytical groups for timely completion of project. Responsible for Scale up and technology transfer along with manufacturing support during troubleshooting at mfg. site. If required, ensuring the physical presence at manufacturing site during critical scale up/GMP batches like clinical batch, engineering batch, PV batches, etc. Regular biweekly updates to vertical heads with conclusion of performed experiments and way ahead. Align the overall development work, experiments with project deliverable timelines and company goals. Empower the team with frequent scientific discussions and energizing them for more productive outcome. Preferred candidates Candidate should be a good team player and comfortably connect inter & intra departmental teammates with expedited productive outcome. Need to demonstrate and continue implementing good documentation practices with data traceability. Should inculcate a scientific acumen in team members and exhibit a good leadership. Strong communication Candidate should be well versed with latest developments in purification techniques and look forward for implementing them in process. Should be expert in handling and troubleshooting of DSP related instruments including purification systems, TFF systems, Nanofiltration, etc.