Director, Pharmaceutical Development, Drug Product Manufacturing

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
• Establish and manage CDMO technical governance, including meeting cadence, performance oversight, escalation pathways, and risk management
• Drive identification, assessment, prioritization, and mitigation of process risks and manufacturing challenges
• Own or co-own process validation strategy for drug product manufacturing, including PPQ strategy and CPV plans
• Lead secondary packaging development activities for late-stage and commercial-readiness drug product programs
• Support regulatory submissions, agency questions, inspection readiness, and PAI preparation related to drug product manufacturing and CMC content
• Manage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners
• Mentor and provide technical guidance to junior team members and cross-functional partners

Requirements

• Bachelors degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline
• 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
• Strong working knowledge of cGMP requirements for OSD manufacturing, ICH Q8/Q9/Q10, and risk-based validation principles
• Proven ability to technically oversee, influence, and hold external manufacturing partners accountable for quality and timelines
• Ability to operate independently in a fast-paced, virtual biotech or pharmaceutical environment

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 and reviewing CMC sections for regulatory submissions
• Familiarity with statistical tools used for process monitoring and manufacturing data analysis
• Experience mentoring technical staff in a pharmaceutical development or CMC environment

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave and fringe perks