Director, Pharmaceutical Development – Drug Product Manufacturing
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Pharmaceutical development director leading outsourced drug product manufacturing, validation, packaging, and CDMO governance. Advancing psychedelic therapeutics for psychiatric and neurological disorders at Definium Therapeutics.
Responsibilities:
- 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
Similar Jobs
Global Client Director – Media, Entertainment, Gaming, Sports
Global sales leader growing Qumulo’s cloud data platform business across media, entertainment, gaming, and sports. Managing MEGS strategy, enterprise sales, forecasting, and senior account executives.
Director, Channel – Space Solutions
Channel sales leader scaling IonQ’s partner ecosystem for quantum-powered space data, satellite, and optical communications solutions. Driving indirect revenue, partner programs, and government and defense pursuits.
Director, Channel – Space Solutions
Channel sales leader scaling IonQ’s partner ecosystem for space data, satellite systems, and optical communications. Driving global indirect revenue through resellers, integrators, defense primes, and government pursuits.
Director of Data and Analytics
Director leading enterprise data strategy, platforms, and BI for Marmon Metal Services. Building Microsoft Fabric and Power BI solutions while guiding analytics teams and business adoption.
Strategy & Transformation Director
Strategy and Transformation Director shaping enterprise strategy and transformation for a healthcare organization. Advising executives and leading cross-functional initiatives across clinical, operational, financial, and organizational domains.
Director, Community Health – Impact
Community health director advancing needs assessments, partnerships, and social-impact programs for Advocate Health. Measuring outcomes and guiding community investments across North Carolina service areas.
Director, Community Health and Impact
Community health director leading needs assessments, social drivers initiatives, and community investments for Advocate Health. Partnering with Georgia facilities and stakeholders to improve equitable health outcomes.
Director, Community Health and Impact
Community health director advancing social-driver and population-health programs for Advocate Health. Leading needs assessments, partnerships, investments, and measurable community impact across Northwest Georgia and Alabama.
Director, Community Health – Impact
Community health director leading needs assessments, health programs, and community investments for Advocate Health’s Illinois hospitals. Driving measurable improvements in social and clinical outcomes.
Associate Media Director
Associate Media Director supporting CBP’s Trusted Traveler Program marketing. Planning, buying, optimizing, and reporting paid media campaigns for domestic and international travelers.
Agency Managing Director – Commercial P&C
Agency Managing Director overseeing profitable growth and strategic partnerships for Amerisure, a commercial property and casualty insurer. Managing agency performance, underwriting influence, and market expansion.
Director of Revenue Cycle Management
Remote RCM Director leading billing operations for Maryland behavioral health providers. Managing payer reimbursement, denials, collections, reporting, and billing teams for Revive BHS.
Director, Provider Services
Director leading healthcare staffing growth, recruitment, sales, and operations for the Provider Services division. Managing teams, pipelines, client retention, and performance across physician staffing.
Associate Director, Request for Proposals
Associate Director managing Medicaid, Medicare, and private healthcare RFP proposals for HSAG. Directing proposal development, compliance reviews, submissions, and business opportunity evaluation.
Director, Americas Benefits Strategy – Enterprise Initiatives
Danaher benefits leader shaping U.S.-focused Americas health and welfare strategy. Driving data-informed programs, vendor governance, and M&A integration across life sciences businesses.
Campaign and Media Director
Campaign and Media Director leading media, digital content, events, and data visualization for the Afghanistan War Commission. Shaping public communications around its final report to Congress.
Senior Director, Global Enablement Programs
Senior Director leading global sales enablement, onboarding, analytics, and AI initiatives. Improving commercial capability and measurable outcomes for Axiom’s on-demand legal talent marketplace.
Senior Director, Transformation & Enterprise Data
Senior Director leading Keyloop’s enterprise transformation portfolio and governance. Driving global programme delivery, executive accountability and trusted group-level data reporting for automotive technology clients.
Senior Director, Strategic Accounts
Regional sales leader driving revenue, account strategy, and team execution across Florida and Georgia. Cengage provides digital education products and platforms to millions of learners.
Senior Director, Strategic Accounts
Regional sales leader driving strategic higher-education accounts for Cengage’s education technology business. Leading revenue growth, forecasting, complex deals, and Strategic Account Directors across California.