Scientist- Downstream Process & Formulation development

Department:

Role:

Opportunity:

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.