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Forma Therapeutics
Watertown, Massachusetts, United States
30+ days ago
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1 - 25 Results of 41
Forma Therapeutics
Watertown, Massachusetts, United States
30+ days ago

Description

Forma Therapeutics (Nasdaq: FMTX) is a clinical-stage biopharmaceutical company focused on the research, development, and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines biological insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. Reporting to the Chief Technology Officer, the Executive Director of Drug Product Development and Manufacturing will be responsible for leading Drug Product (DP) activities across Forma’s portfolio of programs.

About the Role:

  • Lead all Drug Product (DP) efforts, including formulation development (adult and pediatric), process development, as well as the manufacture of DP for clinical – and eventually commercial – purposes.
  • Develop and lead phase-appropriate DP project plans; develop outsourcing strategies, prepare RFPs, and manage the successful execution of plans consistent with corporate objectives and compliant with cGMP requirements.
  • Lead the preparation of the DP section of various regulatory documents (IND, NDA, etc.) and effectively represent the DP function, as appropriate, in interactions with regulatory authorities.
  • Effectively and professionally represent the DP function, and when needed the broader Tech Ops function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners.
  • Effectively integrate DP activities with those of sister CMC functions, including Drug Substance Development & Manufacturing, Analytical Development, Supply Operations, CMC Operations, Quality Assurance, and Regulatory Affairs.
  • Work with Supply Operations to ensure a continuous and uninterrupted supply of CTM to clinical sites and, upon commercialization, of commercial materials to market.
  • Integrate DP activities with those of other corporate functions, including Research, Legal, Finance, and HR.
  • Supervise technical staff (internal and external) and manage consultants as needed to ensure effective execution of activities and attainment of goals.


Requirements

About You:

  • Ph.D. in Chemical Engineering, Material Science, Pharmaceutics, or related discipline with 10 – 15 years of industry experience. MS degrees with commensurate experience will also be considered. 
  • Strong experience required in solid oral dosage form development. Significant hands-on experience in the areas of formulation development, DP process development, and manufacturing.  Experience in Spray Dry Dispersion (SDD) technology as well as the development of pediatric dosage forms are also desired.
  • Experience working in close collaboration with technical, regulatory, quality, project management, legal, finance, and supply chain functions, in a cGMP operational environment.
  • Experience in leading and managing outsourced development and manufacturing efforts, and associated operating budgets.
  • Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs.
  • Desire to work “hands on”, setting priorities, meeting timelines, motivating others, and managing departmental budgets.
  • Superb communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite.
  • Periodic travel to manufacturing and other partner sites is required (approximately 10 – 20 % of time), in accordance with applicable COVID-related travel guidelines.

About Us:

Headquartered in Watertown, MA, we have all the perks you can find in Cambridge (walkable to lunch, shopping, etc.) and more perks that you can’t (ample free parking!) Our diverse portfolio and our commitment to patients sets us apart. Our patients are our true north; our pipeline is our road map. Everyone at Forma is a part of the journey. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn. Click here to apply. #formafuturewithforma

No phone calls please. Resumes from third party vendors will not be accepted.

Job Information

  • Job ID: 59259054
  • Location:
    Watertown, Massachusetts, United States
  • Position Title: Executive Director, Drug Product Development and Manufacturing
  • Company Name: Forma Therapeutics
  • Job Function: Drug Development,
    Manufacturing,
    Product Development
  • Job Type: Full-Time
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