Director/Sr. Director of Drug Product CMC

2 weeks ago

New York, New York, United States EPM Scientific Full time $180,000 - $300,000 per year

Director/Sr. Director of Drug Product CMC

Location:
New York City, NY

Company Overview:

We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies. Their portfolio consists of assets across early and late stage development.

Job Summary:

The Director/Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director/Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones.

Key Responsibilities:

  • Lead the development and implementation of CMC strategies for drug product development and manufacturing.
  • Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing.
  • Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition.
  • Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities.
  • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products.
  • Support regulatory submissions by providing CMC-related documentation and expertise.
  • Lead process optimization, validation, and continuous improvement initiatives.
  • Manage the drug product manufacturing budget and long-range planning.
  • Serve as a subject matter expert during regulatory inspections and audits.

Qualifications:

  • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.).
  • Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions.
  • Proven track record in CMC regulatory submissions (IND, IMPD, NDA)
  • Experience managing CMOs and overseeing technology transfer processes.
  • Excellent problem-solving, project management, and communication skills.
  • Ability to work collaboratively in a fast-paced, dynamic environment.
  • Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE.
  • Willingness to travel as needed (up to 10%).

What We Offer:

  • Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies.
  • Collaborative work environment with professional development and career growth opportunities.
  • Competitive compensation package, including comprehensive benefits and stock options.

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