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Vice President, Chemical Manufacturing and Control (VP-CMC)

Waltham, MA

Vice President, Chemical Manufacturing and Control (VP-CMC)

Skyhawk Therapeutics, a clinical-stage biotechnology company, is seeking a Vice President of Chemical Manufacturing and Control (CMC) to execute our rapidly expanding development pipeline of small molecule therapeutics. This role will be based at our Waltham, MA site in the Boston metro area, with flexible on-site work arrangements. The role will report directly to the EVP of Chemistry with responsibility to the C- Level leadership.

Responsibilities (including, but not limited to):

  • Accountable for executing the stage-appropriate supply of drug substance and drug product for the advancement of Skyhawk’s small molecule therapeutics, from preclinical safety studies through clinical supply and commercial launch.
  • Work with the Senior Leadership team to craft the nimble and efficient drug supply strategy from clinical through commercial.
  • Select, coordinate, and execute with both consultants and Contract Research / Contract Development and Manufacturing Organizations (CRO / CDMO) to supply drug substance and drug product for Skyhawk programs.
  • Supervise or collaborate with the Skyhawk team and subject matter expert consultants in CMC, analytical chemistry, quality assurance, and regulatory affairs to ensure seamless and timely document preparation for stage-gate advancement.

Education/Skills/Experience:
Required

  • PhD in synthetic organic chemistry with 10+ years of relevant postgraduate industry experience
  • An established track-record with prior small molecule CMC leadership position in minimally two of four listed organization types (Commercial-stage pharma, pre-commercial biotech, CRO, CDMO)
  • Demonstrated experience coordinating and authoring the drug substance and drug product sections of regulatory documents (for example IND, NDA)
  • Leadership skills consistent with a VP-level professional. These skills include active listening, clarity in written and verbal expression, and a flexible and enabling response to changes and challenges.
  • An unwavering commitment to patients

Preferred but not required

  • Prior CMC leadership in post-registration supply of a commercial product
  • Bilingual fluency in English and Mandarin

About Skyhawk

Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.

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