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Associate Director/Director, Drug Product Operations

Cambridge, MA

About Theseus

Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): “pan-variant” targeted therapies that address all known drug resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com or follow the company on LinkedIn.

Role Description

Reporting to the Sr. Vice President of Technical Operations, the individual is responsible for directing Drug Product formulation development and manufacturing for the company’s clinical programs. The successful candidate must have a proven track record of effectively managing activities at Contract Development and Manufacturing Organizations (CDMOs).

Key Responsibilities

  • Design, direct and oversee outsourced small molecule formulation development and GMP drug product manufacturing.
  • Develop strategic project and resource plans for company drug development programs, and provide high-level guidance to senior management on drug product requirements.
  • Effectively lead and mentor team members in all matters related to drug product development that complies with global regulatory requirements.
  • Provide guidance for drug product research and development activities consistent with principles of quality by design (QbD) and quality risk management (QRM)
  • Manage priorities and risks to meet corporate objectives and timelines.
  • Author internal technical documents and relevant CMC sections to support global regulatory submissions.
  • Develop relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc.)
  • Budget and manage financials and forecasts for all drug product-related expenses.
  • Represent Drug Product Operations in interdisciplinary teams with colleagues from Drug Substance Operations, Analytical Development, Quality, CMC Regulatory Affairs, Supply Chain, and Program Management

Qualifications

  • D. in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline with at least 15 years of related industrial experience.
  • Extensive formulation and process development expertise across a broad range of dosage forms.
  • Demonstrated experience managing third parties and external service providers (domestic and international), including late-phase and commercial CDMOs
  • Drug product manufacturing experience and a functional understanding of cGMP requirements (experience with process validation and commercial manufacturing preferred).
  • Deep understanding of drug substance properties, solid form science, and analytical chemistry relevant to drug product development.
  • Excellent interpersonal skills, including negotiation skills that ensure corporate outcomes are met.
  • Strong oral/written communication and presentation skills.
  • Experience in the preparation and review of regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
  • Excellent risk management, problem-solving, and crisis management skills.
  • Ability to work in cross-functional teams as related to drug development.
  • Well-versed in the latest technologies, trends, and practices in formulation development and cGMP manufacturing.
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