Manager - MSAT (USP)

Key Responsibilities:

• Lead the MSAT Cell culture Upstream team.
• An executive with extensive expertise in Biologics (Upstream) Development & Manufacturing: Product Technical Life Cycle Management.
• Collaborate with cross-functional teams to facilitate the transfer of upstream processes from development to manufacturing.
• Lead and execute technology transfer activities, ensuring alignment with project timelines and quality standards.
• Provide technical expertise in upstream bioprocessing, to optimize manufacturing processes.
• Conduct risk assessments and troubleshoot issues related to technology transfer and manufacturing.
• Work closely with development teams to gather and document critical process parameters and data for successful transfer.
• Planning and designing using DOE approach for process development and characterization of upstream operations.
• Collaborate with Quality Assurance to ensure compliance with cGMP and other regulatory standards.
• Participate in process validation activities and support the resolution of deviations or discrepancies.
• Contribute to the continuous improvement of technology transfer processes and documentation.
• Identify opportunities for improving the product quality and quantity as per current and future market demand.

Qualifications:

• Education: Masters or Ph.D. in Biotechnology, or related field.
• Experience: 8+ years in biopharma manufacturing, with 5+ years in MSAT or process improvement roles.
• Technical Skills:
• In-depth knowledge of bioprocessing, upstream process development, Manufacturing and process intensification strategies.
• Expertise in QMS, regulatory requirements (e.g., FDA, EMA).
• Proficiency in statistical software (e.g., JMP, Minitab) and root cause analysis tools.
• Soft Skills:
• Strong project management skills, with the ability to lead and influence cross-functional teams.
• Excellent problem-solving, analytical, and communication skills.