Director, Pharmaceutical Development – Drug Product Manufacturing

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $230k - $260k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 3%

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• Serve as the senior technical lead and primary point of contact for CDMOs supporting drug product manufacturing, packaging, testing, and release activities • Lead drug product development and manufacturing strategy across assigned programs, including formulation development, process development, technology transfer, scale-up, process validation, and commercial readiness • Lead technical oversight of clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, deviations, investigations, and associated technical documentation • Establish and manage CDMO technical governance, including meeting cadence, performance oversight, escalation pathways, risk management, and issue-resolution processes • Contribute to cross-functional CMC workstreams with Pharmaceutical Development, Quality, Regulatory CMC, Analytical Development, Supply Chain, Clinical Supply, Program Management, and external manufacturing partners • Drive identification, assessment, prioritization, and mitigation of process risks, manufacturing challenges, and supply-readiness issues • Own or co-own process validation strategy, including PPQ strategy, risk assessments, control strategies, CPV plans, and lifecycle process monitoring • Lead preparation, review, and approval of process validation documentation • Evaluate manufacturing performance data to identify trends, process capability concerns, technical risks, and continuous improvement opportunities • Provide senior technical leadership for manufacturing investigations, deviation resolution, CAPA development, change controls, and post-approval manufacturing changes • Lead secondary packaging development activities for late-stage and commercial-readiness drug product programs • Oversee packaging design, component selection, labeling configuration inputs, packaging line considerations, packaging validation, and supply-readiness activities • Support regulatory submissions, agency questions, inspection readiness, and PAI preparation related to drug product manufacturing, process validation, packaging, and CMC content • Author and/or review CMC sections and technical documentation supporting regulatory submissions, health authority interactions, and lifecycle management • Manage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners and consultants • Provide technical recommendations to senior leadership on manufacturing strategy, CDMO performance, validation readiness, process risks, regulatory readiness, and commercialization decisions • Mentor and provide technical guidance to junior team members, consultants, and cross-functional partners

🎯 Requirements

• Bachelors’ degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline; advanced degree preferred • Minimum 12 years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, CMC, or related functions • Significant experience leading outsourced manufacturing models and managing CDMOs in a virtual or highly outsourced company environment • Demonstrated experience providing technical leadership for drug product development, technology transfer, scale-up, process validation, and commercial readiness • Strong working knowledge of cGMP requirements for OSD manufacturing • Strong working knowledge of drug product process development, formulation development, technology transfer, scale-up, PPQ, and CPV • Strong working knowledge of ICH Q8/Q9/Q10 and risk-based validation principles • Strong working knowledge of manufacturing investigations, deviations, CAPAs, and change management • Strong working knowledge of regulatory expectations for late-stage development, commercial readiness, and inspection preparedness • Proven ability to technically oversee, influence, and hold external manufacturing partners accountable for quality, timelines, technical execution, and issue resolution • Demonstrated ability to lead cross-functional teams and influence senior internal and external stakeholders without relying solely on direct authority • Experience contributing to CMC strategy for regulatory submissions, health authority questions, PAIs, or commercial launch readiness • Strong analytical, communication, documentation, and decision-making skills • Ability to operate independently in a fast-paced, virtual biotech or pharmaceutical environment with significant external partner reliance • Preferred: experience supporting regulatory submissions and PAIs for solid oral dosage products • Preferred: experience with lifecycle management, CPV programs, post-approval change management, and commercial manufacturing support • Preferred: experience authoring and reviewing CMC sections for regulatory submissions related to drug product manufacturing, validation, and packaging • Preferred: familiarity with statistical tools used for process monitoring, process capability assessment, CPV, and manufacturing data analysis • Preferred: experience mentoring technical staff in a pharmaceutical development, technical operations, or CMC 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 • Some fun fringe perks • Additional compensation, including bonus and equity, may be available