Biopharmaceutical Production Manager

4 days ago


King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
About the Role

The Biopharmaceutical Production Manager will be a key member of a dynamic operations team at GlaxoSmithKline, responsible for enhancing and improving processes across biopharmaceutical product development. This role requires a scientific leadership professional with a strong background in biopharmaceutical production and a proven track record of driving process improvements.

Key Responsibilities
  • Process Improvement: Develop and implement process improvements to enhance efficiency, quality, and compliance across biopharmaceutical product development.
  • Leadership and Collaboration: Lead cross-functional teams to drive process improvements and collaborate with stakeholders to achieve business objectives.
  • Regulatory Compliance: Ensure full compliance with all applicable manufacturing and safety regulations, including local policy and procedures, GSK QMS/EHS, CFR/cGMP, OSHA standards, and all applicable environmental regulations.
  • Documentation and Data Integrity: Oversee and approve improvements to standard operating procedures, batch document instructions, and logbooks to ensure good documentation and data integrity practices.
  • Investigations and Troubleshooting: Approve investigations that are the result of safety or compliance issues and lead a values-based culture by displaying and encouraging full transparency.
  • Workforce Planning and Development: Develop and implement a workforce plan that ensures the personnel development and performance management planning for all direct and indirect reports within the department.
  • Production Standards and Manpower Requirements: Establish production standards and manpower requirements to meet delivery schedules and partner with the NPI lead for successful implementation of new products and processes into the facility production equipment and schedules.
Requirements
  • Education: Bachelor's degree in Chemical/Mechanical/Biomedical engineering, Biotechnology.
  • Experience: 7+ years of production in biopharm/biotech or similar technology-based industry, 3+ years of leadership experience, and 5+ years of large scale cell culture or fermentation based processing.
  • Preferred Qualifications: MS or Ph.D. in biological science or biochemical engineering, strong quality/compliance orientation and track record, excellent interpersonal and leadership skills, strong influence and relationship building skills with an emphasis on teamwork, and good written communication, organizational, and computer skills.


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