Director, Pharmaceutical Development – Drug Product Manufacturing

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the senior technical authority and main liaison for CDMOs involved in drug product manufacturing, packaging, testing, and release operations.

• Direct the strategy for drug product development and manufacturing across assigned projects, encompassing formulation development, process development, technology transfer, scale-up, process validation, and readiness for commercialization.

• Provide technical oversight for clinical and commercial drug product manufacturing initiatives, including the review and approval of batch records, campaign plans, protocols, reports, deviations, investigations, and related technical documentation.

• Establish and oversee CDMO technical governance, which includes meeting schedules, performance monitoring, escalation pathways, risk management, and issue resolution processes.

• Collaborate with cross-functional CMC workstreams, including Pharmaceutical Development, Quality, Regulatory CMC, Analytical Development, Supply Chain, Clinical Supply, Program Management, and external manufacturing partners.

• Facilitate the identification, assessment, prioritization, and mitigation of process risks, manufacturing obstacles, and supply readiness challenges.

• Own or co-manage the process validation strategy, which includes PPQ strategy, risk assessments, control strategies, CPV plans, and lifecycle process monitoring.

• Lead the preparation, review, and approval of process validation documentation.

• Analyze manufacturing performance data to detect trends, process capability issues, technical risks, and opportunities for continuous improvement.

• Provide senior technical leadership for manufacturing investigations, deviation resolution, CAPA development, change controls, and modifications after approval.

• Oversee secondary packaging development activities for late-stage and commercially ready drug product programs.

• Supervise packaging design, component selection, labeling configuration inputs, considerations for packaging lines, packaging validation, and activities related to supply readiness.

• Assist with regulatory submissions, address agency inquiries, prepare for inspections, and manage PAI preparations associated with drug product manufacturing, process validation, packaging, and CMC content.

• Author and/or review CMC sections and technical documentation that support regulatory submissions, interactions with health authorities, and lifecycle management.

• Oversee external technical operations, including priorities, budgets, timelines, and deliverables for CDMO partners and consultants.

• Provide technical recommendations to senior leadership concerning manufacturing strategy, CDMO performance, validation readiness, process risks, regulatory compliance, and commercialization decisions.

• Mentor and offer technical guidance to junior team members, consultants, and cross-functional partners.

⛳️ Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related field; advanced degree preferred.

• At least 12 years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, CMC, or related areas.

• Extensive experience in leading outsourced manufacturing models and managing CDMOs in a virtual or highly outsourced corporate environment.

• Proven experience in providing technical leadership for drug product development, technology transfer, scale-up, process validation, and readiness for commercialization.

• In-depth knowledge of cGMP requirements for OSD manufacturing.

• Strong understanding of drug product process development, formulation development, technology transfer, scale-up, PPQ, and CPV.

• Proficient knowledge of ICH Q8/Q9/Q10 and risk-based validation principles.

• Solid understanding of manufacturing investigations, deviations, CAPAs, and change management processes.

• Comprehensive knowledge of regulatory expectations for late-stage development, commercial readiness, and inspection preparedness.

• Demonstrated ability to technically oversee, influence, and hold external manufacturing partners accountable for quality, timelines, technical execution, and issue resolution.

• Proven capability to lead cross-functional teams and influence senior internal and external stakeholders without relying solely on direct authority.

• Experience in contributing to CMC strategy for regulatory submissions, addressing health authority questions, PAIs, or preparing for commercial launch readiness.

• Excellent analytical, communication, documentation, and decision-making skills.

• Capacity to work independently in a fast-paced, virtual biotech or pharmaceutical environment with significant reliance on external partners.

• 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 in 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

• Comprehensive health benefits fully covered, including Medical, Dental, and Vision for you and your dependents.

• 401(k) plan with company matching and vesting after the first month post-start date.

• Flexible time-off policy.

• Generous parental leave provisions.

• A variety of enjoyable fringe benefits.

• Additional compensation options, including bonuses and equity, may be available.