Associate Director, Drug Product Development

Definium Therapeutics; Durham (NC); On-site; USD 150,000 - 202,000; Full time

Benefits offered by this job

100% paid health benefits including M,

401(k) with company match

Flexible time off

Parental leave

Job summary

Definium Therapeutics in the United States seeks an Associate Director of Drug Product Development to lead outsourced manufacturing strategies and CDMO collaborations. You will drive process development, tech transfer, scale-up, and validation, ensuring timelines align with late-stage programs.

The role requires deep expertise in drug product development, CPV/PPQ, and regulatory readiness, with leadership across virtual manufacturing activities and packaging development for commercial readiness.

Qualifications

• 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions.
• Experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment.
• Strong working knowledge of cGMP for OSD manufacturing, drug product development, and PPQ.
• ICH Q8/Q9/Q10 and risk-based validation principles.
• Proven ability to technically oversee and influence external manufacturing partners.

Responsibilities

• Serve as the technical contact for CDMOs supporting drug product development 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 PPQ protocols/reports, risk assessments, control strategies, and CPV plans.
• Evaluate manufacturing performance data to identify trends and opportunities for improvement.
• Lead secondary packaging development activities for a drug product in late-stage development.
• Support packaging design inputs, labeling configuration, packaging line considerations, and secondary packaging validation with partners and stakeholders.

Skills

CDMO management

cGMP knowledge

Drug product development

Technology transfer

Risk-based validation

Education

Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or related

Job description

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

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

Required 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

Preferred Qualifications

• 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

The starting base pay range for this position is $150,000.00-$202,351.00, with compensation determined based on several factors including skill set, years of experience, and geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page.

The Company provides competitive benefits to employees including:

• 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!