Cell Line development / Upstream / Downstream development Scientist

1. Role Overview

The Scientist will be responsible for designing, executing, and optimizing processes involved in the development of mammalian cell lines and scalable upstream and downstream processes for recombinant protein production. The role involves hands-on experimental work, process characterization, and technology transfer to manufacturing.

2. Key Responsibilities

A. Cell Line Development (CLD)

• Develop stable mammalian (CHO / HEK293) cell lines expressing recombinant proteins (e.g., rFSH, monoclonal antibodies, hormones, enzymes).
• Perform transfection, clone selection, screening, and stability studies.
• Utilize techniques like limiting dilution, clone picking, and high-throughput screening.
• Maintain detailed records of vector constructs, host cells, and clone lineage.
• Conduct productivity assessments (ELISA, SDS-PAGE, Western blot, HPLC).
• Ensure regulatory documentation for master and working cell banks (MCB/WCB).

B. Upstream Process Development (USP)

• Design and optimize culture media, feeds, and process parameters for batch, fed-batch, and perfusion modes.
• Scale up processes from shake flasks → bench bioreactors → pilot scale.
• Perform process characterization, including DO, pH, temperature, and agitation studies.
• Implement Design of Experiments (DoE) for optimization.
• Collaborate with analytical teams for titer and quality assessments.

C. Downstream Process Development (DSP)

• Develop purification strategies using chromatographic (Protein A, IEX, HIC, SEC) and filtration techniques (UF/DF, TFF).
• Optimize recovery and yield while maintaining product quality and activity.
• Characterize process impurities (HCP, DNA, aggregates, endotoxin).
• Conduct process scalability and robustness studies.
• Support tech transfer to GMP manufacturing.

D. Cross-functional & Documentation

• Collaborate with Analytical, QA, and Manufacturing teams for process integration.
• Maintain detailed lab notebooks, SOPs, and batch records.
• Present findings in technical reviews and project meetings.
• Adhere to biosafety and GMP/GLP guidelines.

3. Qualifications

• Education:

  M.Sc. / M.Tech / Ph.D. in Biotechnology, Biochemistry, Bioprocess Engineering, or related discipline.

• Experience:

• Scientist: 3–6 years (for Ph.D.) or 5–8 years (for M.Sc./M.Tech) in biopharmaceutical R&D.

• Proven experience in cell line development, upstream or downstream process development for recombinant proteins or biosimilars.

4. Desired Skills

• Hands-on experience with CHO or HEK cell lines.
• Expertise in molecular cloning, transfection, and selection techniques.
• Familiarity with analytical tools (ELISA, HPLC, SDS-PAGE, Western blot).
• Knowledge of bioreactors (Applikon, Sartorius, or similar).
• Proficiency with chromatography systems (ÄKTA, TFF units).
• Understanding of QbD and regulatory expectations (ICH Q5D, Q6B).
• Strong analytical thinking, troubleshooting, and documentation skills.