Associate Scientist Position vacant in Upstream Department, Syngene
|Associate Scientist / Research Scientist|
Job purpose (Briefly describe the objectives of the job)
- The incumbent will be responsible for defining planning and executing fermentation development, process transfer and quality control functions in support of in-process early-stage biopharmaceutical development programs
- will provide oversight and participate in the management and monitoring of cGMP-compliant process development
- and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities.
- Plan, supervise and execute development/optimization of Microbial and yeast fermentation process of biopharmaceutical products
- Primarily responsible for developing scalable and reproducible bioprocesses and for supporting technical execution in manufacturing
- Manage process transfer and preparation and approval of SOPs, review and contribute to regulatory filings
- Monitor process deviations and lead laboratory investigations
- Keeping abreast of changing technologies in the biopharmaceutical industry and the introduction of new methodologies to the development and manufacturing groups
- Proactively incorporate learnings to improve and influence process development and optimization
- Expected to participate in the management and control of document/records for GLP operations.
- Masters or Ph.D. degree in Biochemical or Chemical Engineering, Biochemistry, Cell Biology or related scientific/technical background
- A minimum of 2-10 years previous work experience in the biopharmaceutical or biotechnology industry with at least 2 years supervisory or managerial experience
Technical /functional skills
- Strong knowledge of biological systems (Microbial) required.
- Prior hands-on technical experience (in a laboratory) is required.
- Knowledge of Good Laboratory Practices (GLPs).
- Knowledge of Excel as well as Statistical Data Analysis tools.
- Strong interpersonal skills –communication (oral and written) and presentation skills.
- Ability to work across functions and with teams.
- The ability to build and lead in a fast-paced and high growth environment.
- Excellent problem-solving and decision-making skills.
Other job requirements:
- Absolute commitment to quality and integrity with a dynamic drive to exceed established targets. Innovative problem solver who thinks outside of the box.
- Must be able to connect, communicate and collaborate throughout the organization. Leadership through inspiration with the ability to manage change.