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Director, CMC (RDN17-01)

Watertown, MA

 

Job Summary

FORMA Therapeutics is seeking a creative and highly motivated leader within its CMC Group with expertise in Drug Product development, Tech Transfers, manufacturing at third party Contract Manufacturing Organizations (CMO) and labeling/packaging clinical trial materials at third-party CMOs and/or third-party Clinical Services Organizations (CSO). The successful candidate must be able to effectively manage Clinical Supply Chain (SC) activities within the US and Rest of World.

Responsibilities

  • Oversee CMOs for the development of drug product, manufacturing and release of GMP Clinical Trial Materials (CTM) ensuring all appropriate cGMP guidelines and regulations are met
  • Effectively interact with CMOs to understand the product manufacturing requirements, the necessary equipment, and facility and process support technologies required from CMOs to support the product(s)
  • Perform technical due diligence assessments to select appropriate CMO partners and successfully lead the tech transfer of the manufacturing technology to the selected CMO
  • Participate in the review and negotiation of clinical drug product manufacturing technical/supply agreements with CMOs and CSOs
  • Manage CSOs and provide comprehensive information about clinical supplies and ensuring continuous supply of clinical trial material for all ongoing studies within the US and ex-US locations world-wide. Also ensures on time startup of new studies by having supplies available as required. In addition, responsible for managing clinical packaging, distribution contractors, and providing oversight to other team members as needed.
  • Review protocols and designs appropriate supply chain strategy
  • Design specifications for automated randomization and drug supply management systems
  • Oversee a variety of logistics issues, including but are not limited to supply chain services, inventory control, import-export, shipment of products and third party warehousing
  • Identify key stakeholders within CMC and clinical project teams to ensure on time availability of CTMs
  • Phase appropriately, conduct refinements of manufacturing process, conduct robustness studies and identify critical quality parameters to develop and streamline a manufacturing process that is scalable for potential commercialization. Conduct risk assessments/FMEAs through process development and pre-validation
  • Lead the Demand & Supply Team to provide effective and timely communication regarding inventory levels, shipping status, forecasting and budgetary assessments to line management, Clinical and Finance
  • Establish measures and metrics to define manufacturing and supply chain performance and provide recommendations to management to optimize operations both internally and externally
  • Works closely with clinical team to establish and implement procedures for strategic production planning to ensure adequate supply with diverse cell lines for patients targeted for product indications.
  • Works closely with CMOs to establish and implement production schedules that enable right first time manufacturing while maximizing manufacturing throughput.
  • Work closely with Procurement and IP groups to establishes supplier relationships and service agreements with cost effective distribution of CTMs
  • Works collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high quality level of cGMP produced manufacturing excellence
  • Multitasks to effectively manage multiple activities/projects; ability to work in a dynamic/fast paced environment is essential
  • Work with the functional line to develop and manage fiscal budget

Qualifications (Education, Experience, Knowledge and Skills)

  • Bachelors or post-graduate degree in Science, business or related discipline
  • 10+ years of experience in a Pharmaceutical or Biological manufacturing company with 5+ years in project management
  • 5+ years of clinical and commercial labeling, packaging and distribution experience managing a third-party CSO
  • Sound understanding of formulation development and cGMP manufacturing aspects of various dosage formulations, especially oral dosage forms
  • Demonstrated leadership in process tech transfer to CMO’s
  • Proven experience in trouble-shooting manufacturing equipment and processes, including equipment evaluation, and validation requirements (IQ/OQ/PQ and Mfg Process Validation)
  • Demonstrated ability to work effectively with Chemical Development, Analytical, Formulation, Quality, Regulatory, Clinical Operation and Program Management groups
  • In depth knowledge of clinical supplies, pharmaceutical technology and computer systems (Excel, Word)
  • Excellent organizational skills and multi-tasking abilities
  • Adept at solving complex problems in creative and effective ways
  • Strong interpersonal communication skills, technical writing, decision-making and teamwork
  • Willingness to travel within the US and abroad

About FORMA

FORMA Therapeutics’ scientists are passionate about discovering and developing medicines that will make a difference in oncology, inflammation & immunity, and other serious diseases. The Company’s fully integrated R&D team drives discovery and early clinical development of therapeutics for qualified targets in the areas of epigenetics, protein homeostasis and metabolism. Leveraging a world class network of academic investigators, clinical experts and partners, FORMA combines deep biology insight, chemistry expertise and early clinical development capabilities, to create drug candidates providing profound patient benefit.

FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with additional chemistry operations in Branford, CT. Check us out at www.formatherapeutics.com or follow us on @FORMAInc

Please send resumes to careers@formatherapeutics.com and reference job code # (RDN17-01) in the subject line.

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