Vice President, Manufacturing (Consultant)

Menlo Park, CA 94025

Posted: 11/08/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 16725

Job Description


VP MFG

This role reports directly to the CTO and will act as a manufacturing and  supply chain expert, making decisions that will impact the current and future operations of the Company.  The Incumbent is responsible for outlining and communicating the Company’ s manufacturing and supply chain vision and the implementation of the manufacturing, and supply chain strategies. This person will ensure the manufacturing, and supply chain resources are aligned with the Company’ s business and regulatory needs.

Excellent leadership skills, strategic thinking, strong business acumen, and in depth knowledge of biopharmaceutical/vaccines supply are essential in this role. This Incumbent is expected to be well-versed in current manufacturing, and supply chain trends and to be familiar with business concepts that can be applied in a fast-moving technology arena.

 

Responsibilities:
  • Provide leadership, guidance and support to the Manufacturing and Supply Chain team
  • Manage CMOs and Supply Chain (US and international) including strategic management of partnerships and manufacturing campaigns
  • Responsible for budgets, operations, logistics, and technical staff ensuring availability of clinical stage and commercial material
  • Manage technology transfer to CMOs
  • Manage implementation of manufacturing changes identified by PD for process optimization and scale-up
  • Represent manufacturing ensuring strong collaborative working relationships with key functions including Pharmaceutical Development, Analytical Development, Quality, etc.
  • Represent manufacturing and supply chain to LT, Board, and external stakeholders, preparing materials and presenting as needed
  • Act as subject matter expert (SME) for the manufacturing process in drafting, reviewing, and overall support of regulatory interactions and documentation

Requirements:
  • B.S. with 10+ years of biological manufacturing experience, including upstream and downstream activities
  • At least 5 years of experience working in complex supply chains
  • At least 10 years of management experience, with at least 5 years experience leading a manufacturing team
  • At least 3 years of experience with fill/finish operations
  • Experience with both insect and mammalian cell culture strongly desired
  • Experience working with AAV-based vector is preferred
  • Experience with commercial approval and product launches strongly preferred
  • Broad experience in cGMP biologics manufacturing and regulatory guidelines
  • Experience interacting with regulatory authorities
  • Highly motivated to lead by example and exceed expectations in all aspects of the role
  • Demonstrated competence upstream and/or downstream process operations
  • Demonstrated competence and knowledge of technical issues associated with fill/finish operations
  • Experience managing US and international CMOs is essential
  • Proven technology transfer experience
  • Demonstrated ability to lead and to function in a collaborative/team-oriented CMC environment
  • Ability to communicate effectively and connect with all levels of the organization
  • Strong project leadership and resource management skills
  • Excellent written/oral communication, ability to present and influence

Meet Your Recruiter

Ashley Lee

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