Vice President of Manufacturing

Job Number:    #0227


Location:     Montgomery County area of Maryland
Company:    Well established (the late 1990s) biopharmaceutical company

Focus:           Regenerative therapies - cell therapy
Misc:             There are six key management employees listed at this company and we are responsible for the recruitment of three of them



POSITION SUMMARY                             

 Reporting to the Chief Technology Officer, this is an exciting opportunity to be a key executive to lead, build and launch the company’s cGMP manufacturing organization.

The Vice President (VP) of Manufacturing will head the function ensuring that appropriate scientific, regulatory, and quality standards are followed across manufacturing facility design, construction and validation, GMP operation system establishment, collaboration with contract manufacturing organization (CMO), and commercial production management. The VP of Manufacturing will lead CMC alliance activities as part of the global development of drug substance within the Company and with partners. The VP of Manufacturing will provide technical leadership and CMC expertise including during discussions with Global Regulatory agencies.


Essential Duties & Responsibilities

 The primary responsibilities include management of the GMP manufacturing of biologics functions. The VP of Manufacturing will develop a CMO partnership strategy to support a growing portfolio of late-stage clinical assets. This role will interface extensively with the discovery, quality, regulatory and program management functions.    Other responsibilities include:

  • Supports to establish GMP manufacturing facility at sister company consisting of design, construction, validation of facility, and GMP operation system.

  • Oversees the preparation and management of complex GMP manufacturing facility development plans, budgets, and long-range planning. Collaborates with manufacturing team members to negotiate and administer contracts. Collaborates with other functions on manufacturing matters (e.g., Quality, Regulatory Affairs, Commercial).

  • Provides guidance, mentoring, and development of staff; ensures the team has appropriate skills, capabilities, and resources to meet current and future business needs. Builds the function to support ongoing organizational needs.

  • Provides scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.

  • Ensures all development, manufacturing, and process validation activities relating to drug substance and drug product are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.

  • Supports CMC team members in the management of Contract Manufacturing Organizations (CMOs), contractors, consultants, suppliers, and all outsourced CMC activities. Ensures the selection of appropriate vendors and oversees their subsequent technical management to ensure competence and data integrity through all stages of development.

  • Reviews Technical/Quality agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of the activities.

  • Participates in regulatory CMC strategy development, providing pharmaceutical sciences input to and support for the compilation of regulatory submissions required for clinical trial and marketing applications.

  • Reviews and edits CMC sections and provides input into Regulatory submissions and regulatory approvals (e.g., IND, CTA, BLA, and MAA). Has overall responsibility for the technical content of the Common Technical Document.

  • Participates in and represents CMC in meetings with global regulatory agencies.

  • Presents CMC information and manufacturing plans/updates to the Executive Leadership Team, the Board of Directors, and business partners, as required.


Knowledge, Skills & Abilities


 The ideal candidate will have proven experience leading a world-class manufacturing organization. They will have in-depth drug development experience, knowledge of biologics, CMO management skills, supply chain and logistics experience. This person will be part of a cross-functional team that will be responsible for all stages of development, BLA submission, implementation and oversight of effective strategies to supply drug product for the company’s clinical and commercial needs, and will be responsible for all aspects of cGMP manufacturing including site selection, training, set-up, hiring, departmental requirements, including cost and budget management and long-range planning. They will be highly motivated, have superior communication and organizational skills, a high level of discipline and can work well both independently and in a team environment. This is a “roll up your sleeves”, hands-on role. 


Education & Experience


  • BS in biology, pharmaceutical sciences, chemical engineering, or related scientific discipline and a minimum of 15 years of product/process development and/or commercial manufacturing experience in the pharmaceutical industry, particularly for biologics. An advanced degree is preferred

  • Leadership and managerial experience with a team of CMC development scientists and/or engineers (process chemists, analytical chemists, formulation scientists, technical operations), leading cross-functional projects, planning and delivering results within project deadlines. Participation in portfolio decision-making in a smaller biotech organization is preferred.

  • Demonstrated ability to design and construct GMP manufacturing facility, and to establish GMP operation system

  • Demonstrated ability to manage Contract Manufacturing Organizations (CMOs) spanning all phases of development including contract negotiation.

  • Demonstrated definition of CQAs and CPPs, and effective use of process risk assessment tools (e.g., FMEA, FMECA).

  • Demonstrated expertise in manufacturing process validation, including taking a product through to commercial launch and life-cycle management. Experience with implementation of post-approval changes is preferred.

  • Demonstrated an understanding of US, EU, and ICH regulations and requirements. Experience in Asia including Korean/Japanese regulations and requirements preferred.

  • Demonstrated ability to build effective relationships across global internal and external organizations, preferably with experience in a matrix environment. Experience working successfully with an external business partner (US, EU, Korea, Japan) is highly desirable.



Link to VP of Research & Development position

Link to VP of Regulatory Affairs position








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NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.


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