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Manager, External Manufacturing

Reference Number: 2992
Location: MA

Our client is a biopharmaceutical company focused on developing innovative RNA-based therapeutics.  They have asked us to assist them in their search for a Manager, External Manufacturing.

The Manager, External Manufacturing will focus mainly on establishing the uninterrupted supply of API and sterile drug product in support of the Manufacturing and Supply Chain organizations. This position is responsible for contracting, process development, and production planning with domestic and international contract manufacturing organizations (CMOs). The incumbent will work closely with Technical Development and CMC teams to implement new processes and manage changes.

Major tasks and responsibilities will include:

  • Partners with CMO’s to ensure performance and control over their cGMP operations.
  • Technical support of cGMP contract manufacturing for clinical and commercial processes.
  • Responsible for coordinating with internal teams and CMOs while managing tech transfer of validated commercial manufacturing processes and process improvement initiatives.
  • Leads development and process validation programs.
  • Monitors cGMP compliance by reviewing production batch records with QA and escalating discrepancies to senior management as required.
  • Institutes corrective actions and best practices across all API and fill/finish CMOs.
  • Facilitates API manufacturing, sterile fill finish, packaging, and release of clinical and commercial product.
  • Prepares solicitations for competitive bids, quotations and proposals with the appropriate specifications, terms and conditions.
  • Develops a deep understanding of current and future external supply needs and ability to clearly link supplier utilization to overall strategy.
  • Feasibility assessment of new product and technology concepts.
  • Authors CMC regulatory submission documents for clinical and commercial products.
  • Coordinates development activities with key partners across R&D and Manufacturing.
  • Manages scale-up strategy and implementation for new product introductions.
  • Develops rigorous strategies to reduce costs and supply risk through disciplined analysis, analytics, trending and modeling of key operational data.
  • Develops tools, processes, and criteria to evaluate supplier performance.

We seek candidates with the following qualifications:

  • BA/BS required in Pharmaceutics, Chemistry, Chemical and/or Biomedical Engineering or related scientific discipline. MSc/MBA preferred.
  • 7+ years of experience in the pharmaceutical, chemical, or related industry, with at least 3 years in a position directly related to pharmaceutical development and/or manufacturing.
  • This role requires experience with API and sterile drug product development, as well as experience managing CMOs.
  • Experience working with multiple cGMP manufacturing sites and/or contract manufacturers is desirable.
  • Strong understanding of ICH, FDA, EMA, JP, and industry best-practices pertaining to validation and manufacturing.
  • Hands-on experience with various pharmaceutical unit operations including API manufacturing, formulation, sterile fill finish, and labeling/packaging.
  • Technical knowledge of PMOs (phosphorodiamidate morpholino oligomers) based chemistry or similar is desired.
  • Manufacturing experience of API including solid phase synthesis, purification, and lyophilization.
  • Experience working with regulatory affairs and QA developing comparability strategies to support changes to manufacturing processes.
  • Knowledge of analytical techniques used for the characterization of morpholino oligomer (PMO) molecules including mass spectrometry (MALDI-TOF), and chromatography (RPIP-HPLC, SCX-HPLC).
  • Experience with novel/alternate route drug delivery systems.

 

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 2992. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.