Senior Director, Process Chemistry & Manufacturing

NYC

DUTIES ā€“ RESPONSIBILITIES:

The Senior Director will be responsible for process development of the company’s novel therapeutic and imaging products. The individual will also responsible for manufacture of therapeutics and active pharmaceutical ingredients at external Contract Manufacturing Organizations (CMOs). This is a key leadership position that will interface with various functions at the company as well as the company’s partners to ensure timely and cost-effective development and manufacturing of their therapeutics for clinical supply and commercial launch.

The major functions to be performed in this position are as follows:

  • Lead in-house and outsourced activities to develop and optimize processes for the company’sā€™ novel therapeutics or imaging agents
  • Lead outsourced development and manufacturing activities for small molecule active pharmaceutical ingredients and/or precursors
  • . Establish partnerships with CMOs, manage tech transfer and GMP manufacturing for clinical drug supply
  • Establish and maintain in-house Process Sciences lab to perform innovative process chemistry and analytical work related to development of their therapeutics
  • Technical writing and review of CMC related regulatory documents, SOPs, Quality Events, RFPs, etc.

QUALIFICATIONS:

  • Education: Ph.D. in Chemistry/Organic Chemistry
  • Experience: Candidates should have a minimum of 7-10 years relevant work experience in organic process chemistry and formulation.

TECHNICAL SKILLS:

  • Knowledge and experience in the following areas:
  • Experience in commercial product manufacturing and drug supply chain a plus
  • Ability to properly assess resources and plan accordingly
  • Attentiveness to details; strong communication and coaching skills; team-oriented focus; strong planning and organization skills
  • Willing to travel when needed
  • Experience with technetium, lutetium, indium and iodine radiopharmaceutical isotopes not necessary but would be an asset

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