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Associate Director, Drug Product Development

3 months ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 5

Description

  • Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities.
  • Lead oversight of drug product development work, including process development, tech transfer, scale-up, and validation.
  • Provide technical leadership for clinical and commercial manufacturing campaigns, including review and approval of batch records, plans, protocols, reports, and investigations.
  • Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges.
  • Develop and support process validation strategies in collaboration with internal and external stakeholders.
  • Oversee preparation, review, and approval of validation documentation, including PPQ protocols and reports, risk assessments, control strategies, and CPV plans.
  • Evaluate manufacturing performance data to identify trends, process capability concerns, and improvement opportunities.
  • Lead secondary packaging development activities for a late-stage drug product.
  • Support packaging design, component selection, labeling inputs, packaging line considerations, and secondary packaging validation with external partners and internal stakeholders.

Requirements

  • Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline.
  • 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions.
  • Demonstrated experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment.
  • Strong working knowledge of cGMP requirements for OSD manufacturing.
  • Strong working knowledge of drug product process development, formulation development, tech transfer, scale-up, and PPQ.
  • Strong working knowledge of ICH Q8/Q9/Q10 and risk-based validation principles.
  • Strong working knowledge of manufacturing investigations and change management.
  • Proven ability to technically oversee and influence external manufacturing partners.
  • Experience supporting regulatory submissions and PAIs for solid oral dosage products (preferred).
  • Experience with lifecycle management, CPV programs, and post-approval change management (preferred).
  • Experience authoring or reviewing CMC sections for regulatory submissions related to drug product manufacturing (preferred).
  • Familiarity with statistical tools used for data analysis (preferred).
  • Prior experience in a virtual or highly outsourced biotech environment (preferred).

Benefits

  • Starting base salary of $150,000 to $202,351, depending on skill set, years of experience, and geographic location.
  • Additional compensation may include bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match.
  • 401(k) vesting begins after the first month of employment.
  • Flexible time off.
  • Generous parental leave.

Interested in this position?

Apply directly on the company website

Apply Now

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