New job posted by Integrated Biopharma AND Pharma Solution. Please check the JD, if you think you match the requirements, please apply
#biotechjobs #Process #biologicsmanufacturing
About the job
Senior Scientist/ Scientist – Process Development for Biologics/Biotherapeutics will support the development and manufacturing of the client’s products and processes. This role supports the client’s technical team in development for manufacturing process (upstream & downstream), process technology transfer, scale-up, real-time monitor, and documentation)
Specific Duties, Activities, And Responsibilities
- Support for process development, process technology transfer, scale-up, real-time monitor, and support client’s technical team on recombinant protein products.
- Apply technical, functional, business, and/or industry knowledge to design experiments with DoE and QbD approach; provide scientific consultation to the department/ discipline/group.
- Assess transferred process and process analytical procedures.
- Apply technical, functional, and industry knowledge to design and evaluate process, review and analyze data, frame early and late phase needs.
- Write and review technical documents for accuracy, thoroughness, and regulatory compliance
- Position requires to travel to client’s site for 1-2week/ month (Majorly international traveling)
- PhD/MSc in Chemistry, Biochemistry, Biotechnology or B.Tech/ M.Tech in Biochemical engineering or related scientific field with 3-5 years of related industry experience
- Experience in mammalian cell-culture/microbial/yeast-based downstream process development, deep knowledge of biologics/biosimilar downstream process development strategies, and familiarity with current industry best practices.
- Experience in downstream process routine operation, process characterization, and optimization, knowledgeable in automation, real-time monitor and control of DSP.
- Experience with preparation of regulatory documents (FDA)
- Demonstrated problem-solving skills and written/verbal communication skills.
- Ability to work independently within a team environment.
- Adequate knowledge of cGMP experience is preferred.