Director of Drug Product Manufacturing

Lead the Drug Product Manufacturing team at Xenon Pharmaceuticals as a Director/Senior Director in Boston, MA, or Burnaby, BC. This hybrid role focuses on late-phase process development and commercial manufacturing.

Xenon Pharmaceuticals is seeking a Director/Senior Director, CMC, Drug Product Manufacturing. The successful candidate will oversee late-phase drug product development, ensuring compliance with quality standards while managing external contract manufacturing organizations. This leadership role requires a deep understanding of CMC processes in a collaborative environment.

Key Responsibilities:

• Lead late-stage process development and manufacturing scale-up

• Oversee drug product validation and commercial manufacturing

• Manage development activities related to manufacturing compliance

• Collaborate with supply chain and quality teams for success

• Author and review CMC documents for regulatory submissions

Requirements:

• PhD in relevant field with 10 years experience

• Proven late-stage manufacturing management experience

• Strong knowledge of cGMP regulations and standards

• Excellent communication and leadership skills

• Ability to build high-performing teams

Drive drug product success at Xenon through your extensive CMC leadership experience and commitment to innovation.
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