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Senior Manager, Drug Product Manufacturing

Reference Number: 2712
Location: MA

Our client is a rapidly growing, specialty biopharmaceutical company.  They have retained us to assist them in their search for a Senior Manager, Drug Product Manufacturing.

The Senior Manager, Drug Product Manufacturing is responsible for supervising contract manufacturing organizations related to commercial drug product manufacturing in order to meet quality specifications and inventory goals.  This position will act as a liaison between the company and contract manufacturing organizations for the manufacturing of sterile drug products and will work closely with Quality Assurance, Quality Control, Regulatory and Supply Chain groups for the management of technical issues, scheduling, batch review and release, process validation and regulatory support.

Major tasks and responsibilities will include:

  • Responsible for managing projects and manufacturing decisions which have very high impact on project schedules or business goals.
  • Manages cross-functional teams and leverages external contract manufacturing organizations to achieve business goals.
  • Defines project budgets and schedules and ensures project performance in accordance.
  • Serves as a technical expert within the organization to provide resolution to most complex problems.
  • Uses technical expertise and organizational knowledge to achieve business goals in effective ways.
  • Responsible for monitoring manufacturing performance and suggesting/implementing improvements which have significant positive impact for the business.
  • Provides performance updates to upper management.
  • Manages commercial manufacturing for sterile drug products but experience with manufacturing of oral dosage drug products may also be considered.
  • Supports early and mid-stage development projects as needed.

We seek candidates with the following qualifications:

  • BS degree or higher in biology, biochemistry, chemistry, or chemical engineering.
  • 7 years of related experience within biotechnology and/or the pharmaceutical industry.
  • 4-5 years of experience working in a GMP environment.
  • Well versed in GMP regulations and possess experience with process validation and project management.
  • Technical expertise in sterile drug product manufacturing.  Oral dosage manufacturing experience may also be considered. 
  • Ability to handle multiple tasks and possess excellent supervisory, organizational and interpersonal skills to communicate effectively in a diverse team environment as well as a willingness to travel.
  • Focuses on delivering excellent results and improving the performance of oneself and of the company.
  • Takes initiative to try new approaches, while still following the rules (e.g., company, government and ethical).
  • Takes action to surpass one’s own past performance, excel at an objective measure or goal, or do something that has never been done before.
  • Recognizes opportunities and/or issues and applies analytical and creative thinking to maximize performance.
  • Looks for underlying causes of events and/or consequences of actions.
  • Sees the complexity of issues (A leads to B leads to C leads to D) in order to solve them.
  • Expresses ideas and information clearly and accurately.  Speaking/writing concisely and clearly.  Adapts one’s communication style depending on the audience’s interest, needs or expectations.
  • Proactively and tactfully addresses concerns with others when problems persist.
  • Leverages a deep understanding of oneself in order to increase one’s effectiveness.
  • Knows one’s strengths and weaknesses, proactively asks for feedback to balance self-perception, and is resilient.
  • Up to 25% travel.

 

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 2712. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.