SUN PHARMA
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Function: R&D Biotechnology – DSP, R&D Biotechnology – UPS
Quaification:
PhD/Masters in Biochemistry or Biotechnology, PhD/Masters in Biochemistry or Biotechnology
Grade: Manager/Sr. Manager
Experience: 8-15 years
Brief Job Description:
•Establish and lead the downstream group within the Biological Drug Substance Unit with process and operations-based expertise to support delivery (on time and within the budget) of developed purification processes and of clinical batches of purified recombinant proteins
•Responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for scale- up and GMP production
•Expertise in downstream process development of large molecules recombinant protein and monoclonal antibodies.
•Planning of lab scale studies for development, optimization and characterization of upstream process.
•Exposure to Global market requirements related to biosismilars.
•Participating in project planning, including timelines and resources for internal and CDMO projects.
•Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments.
•Seeking and identifying improvement and optimization of the process with regards to technical as well as economic aspects.
•Collaboration with DSP, analytical, PM, QA/QC, Regulatory, IP and external CDMO clients in order to achieve results.
•Supporting all activities related to setting up process development lab with good laboratory practices and organizational and safety standards.
•Good exposure for CMC support for global biotech product filing.
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