Shilpa biologics hiring for the department of Research and Development.
R&D Upstream Process Development – Mammalian cell culture(Biologics).
Vacant positions: Manager, Jr. Research Associate and Sr. Research Associate.
Experience required: 3-12 years.
Location: Dharwad, Karnataka.
- Responsible for upstream process development for biosimilars (Monoclonal antibodies, Fusion proteins, Glycoproteins) in CHO cells.
- Development and maintenance of seed, and shake flasks for fermentation.
- Hands-on experience with setting up, running, handling, and sampling glass bioreactors of capacities ranging between 250ml to 10L from Sartorius and/or NBS.
- Hands-on experience in running AMBR or 50L SUB will be added advantage.
- Hands-on experience in sterile basal media and feed additives preparation is required.
- Experience in analyzing process runs to establish optimal process parameters and transfer from R&D to manufacturing.
- Hands-on experience in the improvement of product titer and quality for Monoclonal Antibody/ Fusion proteins by optimizing feeding strategy and process parameters.
- Maintaining GLP batch records is mandatory, as identifying and incorporating the latest fermentation technologies into development programs for existing and new molecules.
- Senior Associates will be additionally responsible for: experimental design, planning, execution, and data interpretation for process development.
- Technology transfer and TTD preparation.
- Expected to be team player with potential leadership qualities.
Educational qualification; BSc, MSc, BE or PhD degree in Biochemical Engineering or related fields.
- Strong background in mammalian cell culture (CHO, HEK293), process development, optimization and scale-up/down.
- Strong background in mammalian and microbial process primary recovery (centrifugation, depth filtration) optimization and scale-up/down.
- Extensive experience in biologics (mAbs, recombinant proteins, vaccines) late-phase process characterization, tech transfer, manufacturing support and troubleshooting.
- Strong knowledge in PAT technologies, GMP / ICH guidelines, and CMC experience.
- Advanced cross-functional communication, written, and presentation skills.
- Effective organizational and staff management skills.
APPLICATION PROCESS; Interested candidates can share their CVs to firstname.lastname@example.org