Company: Nimbus Search Partners

Location: Gaithersburg, MD

Industry: Life Science

EmploymentType: Full-Time

CloseDate: 09/25/2017

Address: Gaithersburg, MD 20850

Salary: Competitive


TITLE:             Vice President, cGMP Manufacturing
Location:       Maryland Or Remote (Travel to sites in Asia and US)
 Background: Our client is a Global clinical-stage biopharmaceutical company which is in the process of establishing its operations in the US and is expanding its executive leadership with a several key roles.

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 cGMP Manufacturing will head the function ensuring that appropriate scientific, regulatory, and quality standards are followed across process chemistry, analytical chemistry, formulation development, supply chain activities, and manufacturing/commercial production. The VP will lead CMC alliance activities as part of the global development of drug substance within the Company and with partners. The VP will provide technical leadership and CMC expertise including during discussions with Global Regulatory agencies.
The primary responsibilities include management of the process development and clinical manufacturing functions. The VP, cGMP 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
The ideal candidate will have proven experience leading a world class manufacturing organization. They will have in-depth drug development experience, knowledge of chemistry, pharmaceutical science and engineering, CMO management skills, supply chain and logistics experience. She/He will be part of a cross functional team that will be responsible for all stages of development, NDA submission, scale up, launch preparation, 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.


Required Skills:

  • Builds, leads and oversees the CMC function consisting of Process Development, Analytical Development, Formulation Development, Manufacturing, and Supply Chain.
  • Oversees the preparation and management of complex CMC development plans, budgets, and long-range planning. Collaborates with CMC team members to negotiate and administer contracts. Collaborates with other functions on CMC matters (e.g., Quality, Regulatory Affairs, Commercial). Ensures the CMC function is adequately represented on Global Program Teams.
  • Provides strategic guidance for cross-functional plans particularly coordinating non-clinical, clinical and CMC activity
  • Provides guidance, mentoring, and development of staff; ensures 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 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 l Regulatory submissions and regulatory approvals (e.g., IND, CTA, NDA, 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.
Required Experience:
  • PhD in 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 small molecules and solid, oral dosage forms.
  • 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 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 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.