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VP/Head of Manufacturing (Biologics)

Reference Number: 2771
Location: Northeast

Our client is a clinical-stage biotechnology company.  They have asked us to assist them in their search for a VP/Head of Manufacturing (Biologics).

The VP/Head of Manufacturing (Biologics) is responsible for the manufacturing strategy, organizational design, and operations for our client.

Major tasks and responsibilities will include:

  • Develops and executes manufacturing strategy.
  • Manages all aspects of GMP manufacturing processes for producing highly complex biologics for clinical studies.
  • Oversees Contract Manufacturing strategy including identifying partners, conducting full due-diligence, negotiating mutually beneficial contracts, and fostering strong partnerships.
  • Develops long-range contingency strategy for building internal biologic manufacturing capabilities.
  • Implements operational excellence and system improvements to continuously enhance interactions with manufacturing sites.
  • Provides oversight of tech transfer.
  • Key member of leadership team - assumes full ownership in ensuring that all manufacturing objectives are met.
  • Ensures that product is manufactured to the highest quality standards and in accordance with applicable regulations and procedures.
  • Drives a culture of continuous improvement.
  • Reviews and approves change orders affecting production processes and equipment.
  • Develops production budgets for clinical trials including the timelines for achieving their endpoints in collaboration with the clinical group.
  • Creates a favorable pricing environment with CMOs.
  • Maintains and improves electronic batch record master recipes and SOPs.
  • Coordinates and approves validation activities for manufacturing operations to support clinical manufacturing and ensure capability of meeting clinical production demands.
  • Constructs strategy for potential product launch to allow for seamless advancement of product portfolio.
  • Formulates, monitors, and controls budgets, manpower, and capital expenditures.
  • Works as an effective team member with others in Executive Management, Operations, and R&D to identify and accomplish company objectives.

We seek candidates with the following qualifications:

  • A minimum of a BS degree in science or engineering (MS preferred), with at least 15 years of relevant biopharmaceutical manufacturing experience is required.
  • Extensive experience with clinical and commercial manufacturing techniques related to highly complex biologics, vaccines, or other relevant products.
  • Experience leading commercial manufacturing operations is preferred.
  • Excellent influencing skills and the ability to navigate global relationships with manufacturing plants (CMOs or pharma/biotech companies).
  • In-depth technical knowledge of biotechnology plant operations is required.
  • Demonstrated ability to formulate, implement, and manage complex GMP manufacturing processes for clinical and commercial applications.  This includes knowledge of GMP facilities that meet technical and regulatory requirements.
  • Expert knowledge in cGMP compliance for commercialization of biologicals is required.
  • Experience in decreasing the cost of manufacture and arriving at profitable COGS for the commercial product, especially for complex personalized immunotherapies.
  • Expertise in providing proper oversight of tech transfer.
  • Must have a business-oriented mindset.
  • Experience managing outside contract manufacturing groups and production activities is preferred.
  • Strong interpersonal skills and demonstrated ability to communicate with a diverse team to bring about successful product release from production activities is a must.
  • Experience taking the necessary steps to insure approval with pre-BLA inspections.
  • Experience with BLA filings.
  • Must possess strong analytical, numerical, and reasoning abilities.
  • Positive, can-do attitude is required to effectively tackle problems and interface with the other functional areas of the company on a matrix basis.
  • Must be flexible and open to new ideas and strategies.
  • Demonstrated ability to get results and lead innovation and change.
  • Excellent oral and written communication and presentation skills are required.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2771. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.