Associate Director, Drug Product Development
About The Position
Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric disorders using psychedelics. Our lead candidate targets generalized anxiety, major depressive disorder, and posttraumatic stress disorder, while another candidate addresses social communication challenges in autism spectrum disorder. We are dedicated to advancing a new generation of therapeutics to address the underlying causes of psychiatric and neurological disorders, aiming to transform mental health care. Headquartered in New York and trading on Nasdaq (DFTX), we are committed to moving psychiatry forward. The Associate Director, Drug Product Development is a critical leadership role within the Pharmaceutical Development team. This position is responsible for managing outsourced drug product development and manufacturing activities from early to late-stage development. The role involves serving as the primary liaison with Contract Development and Manufacturing Organizations (CDMOs) for drug product manufacturing and testing. Key accountabilities include planning, coordinating, and driving all manufacturing-related activities, from process development through to commercial readiness. This role demands significant technical expertise in drug product process development, formulation, technology transfer, scale-up, process validation, and continued process verification (CPV). Strategic oversight in a virtual manufacturing setting is essential. Additionally, the Associate Director will manage secondary packaging development for a late-stage product, ensuring alignment with design, qualification, supply readiness, and regulatory timelines.
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
Nice To Haves
- Experience supporting regulatory submissions and PAIs for solid oral dosage products
- Experience with lifecycle management, CPV programs, and post‑approval change management
- Experience authoring or reviewing CMC sections for regulatory submissions related to drug product manufacturing
- Familiarity with statistical tools used for data analysis
- Prior experience in a virtual or highly outsourced biotech environment
Responsibilities
- Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities
- Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation
- Provide technical leadership for clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, and investigations as applicable
- Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges, ensuring timely resolution of technical issues
- Contribute to the development of process validation strategies for drug product manufacturing in collaboration with internal and external stakeholders
- Oversee preparation, review, and approval of process validation documentation, including process performance qualification (PPQ) protocols/reports, risk assessments, control strategies, and continued process verification plans
- Evaluate manufacturing performance data to identify trends, process capability concerns, and opportunities for continuous improvement
- Lead secondary packaging development activities for a drug product in late-stage development
- Support development of packaging design, component selection, labeling configuration inputs, packaging line considerations, and secondary packaging validation activities with external partners and internal stakeholders
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave
- Some fun fringe perks!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
