Job Description

We are seeking a dynamic and experienced Scientist in Fermentation for Active Pharmaceutical Ingredient (API) development to develop highly efficient, cost effective, robust and scalable fermentation especially downstream processes (DSP) for intermediates/APIs.

Roles & Responsibilities

1. Process development for the extraction and purification of biomolecules from recombinant or classical fermentation to meet the API specifications. It may include but not limited to chromatographic methods, membrane-based purification, iso-electric precipitation and crystallisation.
2. Design and conduct experiments related to process optimization and/or feasibility studies to develop safe and robust process keeping in view QbD principles and plant execution.
3. Maintain GLP (good laboratory practices) & GDP (good documentation practices) in the laboratory in order to adhere to SOPs & compliance.
4. Participate in the smooth running of lab meetings and contributes to troubleshooting for potential causes of experimental failures and process performance aspects as relevant.
5. Data collation and presentation in a comprehensive manner for further analysis.
6. Generation of technical presentations elaborating each experimental outcome in order to communicate technical information within the function.
7. Maintain inventory of experiments and ensure completion and draw proper conclusion of each experiment.
8. Draft descriptive scientific reports facing team deliverables (e.g., Process development summary, Tech memo, Process description summary, campaign planning and protocols, etc.) maintaining global quality and as per regulatory standards.
9. Collaborate with DQA for review, data authentication and archival of LNBs, campaign plan/ protocols/ reports.
10. Oversee lab operations, equipment maintenance, safety and quality.
11. Ensure compliance of the team with safety and quality standards and systems for smooth lab functioning.
12. Coordinate with ‘Lab-Ops’ and ‘Engineering’ teams in case of equipment break-down to minimize the downtime.
13. Ensuring the availability of RMs and consumables required for project.
14. Facilitate plant execution and solve scale up related issues at plant.
15. Share common work in the laboratory to help smooth execution of projects.
16. Support the internal & external customer (AR & D, TSD, IP, RA, DQA and cross functional team) by providing technical inputs in order to maintain strong relations with customers.
17. You will be responsible to develop a robust process through initiating, designing, developing, executing, and implementing scientific research projects in collaboration with others. This involves designing and conducting experiments, collecting and interpreting data, and interacting with relevant experts to ensure successful scale-up and technology transfer.
18. You will be responsible to investigate the feasibility of applying scientific principles to potential inventions, participate in patent application development, coordinate interdepartmental activities, and contribute to scientific literature and conferences.
19. You will be responsible for carrying out validations of the optimized process, actively participating in tech transfer, and providing plant support during scale-up, troubleshooting issues, and monitoring plant performance relative to laboratory results for the designated stages. Additionally, you would assist in preparing reports and documentation necessary for gate clearances.
20. You will be responsible to conduct stage wise drafting and compilation of regulatory documents and data as per the guidance to assist in Drug Master filling (DMF) and approval for drug substance.
21. You will be responsible to develop scientific acumen & innovation culture by reading, discussing scientific literature and be updated with the new developments in one’s own area of work- Look for opportunities for application of new learnings in discussion with experts.

Qualifications
Educational qualification: M.Tech / M.S (Research) in biological sciences /Biotechnology/Biochemical Engineering

Experience -Minimum work experience: 3 years of High cell density fermentation downstream process development.
Number of positions – 2

Skills & attributes:
Technical Skills

1. Good understanding of pharma product development, Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
2. Experience in fermentation (upstream/downstream).
3. Hands-on laboratory/pilot scale process experimentation in downstream
4. Knowledge of microbiology, DNA technologies, metabolic engineering, biochemistry, Design of Experiments (DOE) and screening techniques is an advantage
5. Theoretical knowledge of International Council for Harmonisation (ICH) guidelines on process validation

Behavioural Skills

1. Excellent communication and interpersonal skills.
2. Strong analytical and problem-solving abilities.
3. Business Acumen & Decision Making.
4. Performance oriented and good in developing and leveraging relationship.
5. Ability to work collaboratively with own team and cross-functional teams.
   Work location: Raichur, Karnataka
   Company: Shilpa Pharma Life Sciences Ltd.
   Email CV to enzymes@shilpapharma.com