Purification Process Development -Senior Manager-R&D :Biocon
Job description
- The individual will be leading a mid-sized team of scientists and engineers involved in downstream process development of protein purification.
- The candidate should have in-depth understanding of Chromatography, Filtration, & UF/DF.
- The candidate will be expected to monitor and lead development of the laboratory scale process, lead and support technology transfers (of the developed process steps) from R&D to pilot plant and manufacturing
- Candidate should have good exposure with advanced tools for faster process optimization at small scale
- Candidate should have direct exposure of process characterization studies performed for a regulated market application. Candidate should be familiar with DOEs, FMEA, and be experienced with JMP or other statistical software.
- The candidate will be expected to write and review technical reports
- The candidate will be expected to actively participate and add values in cross functional meetings and communicate the key technical findings
- Candidate will be participating and contributing actively in key regulatory filling
- The candidate is required to actively display multifunctional skills, manage teamwork and ensure good lab practices
- Should have exposure with facing audits for CMC related questions or queries
- PhD/M.Tech in Bioprocess Technology/ Biochemical/ Chemical Engineering/ Biotechnology/ Biochemistry, or other relevant science or engineering field with minimum of 8+ year’s post-PhD/12+ year’s post-M Tech experience in purification process development and scale-up for protein therapeutics, preferably monoclonal antibodies
- Proven track record of regulatory filing of biological therapeutics
- Proven track record of building and managing high-performing teams
Technical and soft-skills requirements
1) Comprehensive knowledge of chromatography and filtration theory and techniques, and protein chemistry
2) Strong communication, inter – personal and presentation skills
3) Person should have good experience of leading mid-sized team
4) Should be experienced in the process of recruitment, performance appraisal and training.
