Director, Pharmaceutical Development, Drug Product Manufacturing

A key technical and strategic leader within the Pharmaceutical Development organization, responsible for leading outsourced drug product development and manufacturing activities across early- and late-phase development, commercial readiness, and lifecycle management. This individual will serve as the primary technical and strategic lead for CDMO partners supporting drug product manufacturing and testing, and will be accountable for defining, planning, coordinating, and driving manufacturing-related activities from formulation and process development through technology transfer, process validation, continued process verification, and commercial supply readiness.

This role requires deep technical expertise in drug product process development, formulation development, technology transfer, scale-up, process validation, and continued process verification, combined with the ability to provide senior-level oversight in a virtual manufacturing environment. The Director will lead CDMO governance and technical decision-making, influence cross-functional CMC strategy, and ensure that external manufacturing partners are aligned with program timelines, quality expectations, regulatory requirements, and commercial-readiness objectives.

The Director will also lead secondary packaging development activities in support of late-stage and commercial-readiness programs, ensuring alignment of packaging design, qualification, supply readiness, labeling configuration, validation, and execution within program timelines and regulatory expectations.

Key Responsibilities

• Serve as the senior technical lead and primary point of contact for CDMOs supporting drug product manufacturing, packaging, testing, and release activities
• Lead the 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 involving 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 across internal and external stakeholders
• Own or co-own process validation strategy for drug product manufacturing, including PPQ strategy, risk assessments, control strategies, continued process verification plans, and lifecycle process monitoring
• Lead preparation, review, and approval of process validation documentation, including PPQ protocols and reports, validation master plans, risk assessments, control strategies, CPV plans, and associated regulatory-supporting 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 with external partners and internal stakeholders
• 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 relevant CMC sections and technical documentation supporting regulatory submissions, health authority interactions, and lifecycle management activities
• Manage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners and consultants supporting drug product and packaging development
• 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 involved in drug product development and manufacturing activities

Required Qualifications

• 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
• Drug product process development, formulation development, technology transfer, scale-up, PPQ, and CPV
• ICH Q8/Q9/Q10 and risk-based validation principles
• Manufacturing investigations, deviations, CAPAs, and change management
• 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 Qualifications

• Experience supporting regulatory submissions and PAIs for solid oral dosage products
• Experience with lifecycle management, CPV programs, post-approval change management, and commercial manufacturing support
• Experience authoring and reviewing CMC sections for regulatory submissions related to drug product manufacturing, validation, and packaging
• Familiarity with statistical tools used for process monitoring, process capability assessment, CPV, and manufacturing data analysis
• Experience mentoring technical staff in a pharmaceutical development, technical operations, or CMC environment