Senior Director Manufacturing Biopharmaceutical CDMO

Employment Type

: Full-Time

Industry

: Scientific Research



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Senior Director Manufacturing Biopharmaceutical CDMO


Harrison Frazer are working exclusively with a global CDMO to head hunt for a Senior Director of Manufacturing to be based on site in their facility located in Pennsylvania. The individual will be responsible for the organization, planning, compliance, coordination, and execution of all GMP Manufacturing operations for clinical and commercial production. This position will lead and coordinate the required internal resources to develop and execute the near and long-term strategy to maximize suite utilization, and proactively plan for changing conditions. The Senior Director of Manufacturing has the responsibility to ensure smooth, consistent, cost effective, and compliant product manufacture to meet the pipeline demand and assure departmental and corporate goals are achieved. The position requires collaboration across the organization to deliver on site goals, operational excellence initiatives, and continuous quality improvements. Previous experience in a CDMO environment is a plus, particularly in the area of virus manufacturing and vaccine development.


Responsibilities:

Provide oversight and management of BDS (upstream, downstream) and DP (formulation and filling) manufacturing operations

Develop and introduce best-in-class master production scheduling practices through a thorough evaluation of the current planning and production processes.

Provide technical expertise in process design, optimization, and scale-up for complex manufacturing candidates.

Participate as a key member of the Operations Management Team (OMT) by proactively engaging cross-functionally to achieve site goals. Ensure that reporting staff understand the shared responsibilities for goals and responsibilities.

Lead, develop, and mentor department management staff, with an emphasis on functional and cross-functional teamwork, planning, follow-up, and effective communication.


Requirements

  • Master s / PhD. degree in an Engineering or Science related discipline
  • Successful leadership of clinical and/or commercial vaccine production cell culture, clarification, or purification processes
  • Minimum of 10 years direct management level experience in the Biotechnology Industry, CDMO experience a plus.
  • Prior work experience in a GMP operations function (Cell Culture, Purification)
  • Strong analytical and technical skills

If this opportunity could be of interest and aligns with your background and experience please reach out to ...@harrisonfrazersearch.com with a copy of your resume and availability to speak.


Associated topics: antibody, cytometry, dietician, disease, drug, immuno oncology, immunology, nephrology, protein, trauma

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