[Hiring] Associate Director, Drug Product Development @Definium Therapeutics

Role Description

The Associate Director, Drug Product Development is a key technical leader within the Pharmaceutical Development organization, responsible for overseeing outsourced drug product development and manufacturing activities across early and late phase development. This individual will serve as the point of contact for CDMO partners supporting drug product manufacturing and testing and will be accountable for planning, coordinating, and driving manufacturing-related activities from process development through commercial readiness.

This role requires strong technical expertise in drug product process development, formulation development, technology transfer, scale-up, process validation, and continued process verification (CPV), as well as the ability to provide strategic oversight in a virtual manufacturing environment. The Associate Director will also oversee secondary packaging development activities in support of a product in late stage development, ensuring alignment of packaging design, qualification, supply readiness, and execution within program timelines and regulatory expectations.

Key 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.

Qualifications

• 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.
• Drug product process development, formulation development, tech transfer, scale-up, and PPQ.
• ICH Q8/Q9/Q10 and risk‑based validation principles.
• Manufacturing investigations and change management.
• Proven ability to technically oversee and influence external manufacturing partners.

Requirements

• 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.

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 and some fun fringe perks!