Director, Pharmaceutical Development – Drug Product Manufacturing

Definium Therapeutics

. Serve as the senior technical lead and primary point of contact for CDMOs supporting drug product manufacturing, packaging, testing, and release activities .

Posted 9/30/2026full-timeRemote • United StatesLead💰 $230,000 - $260,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in drug product development, manufacturing science, and technical operations, with a strong focus on process validation, regulatory compliance, and cross-functional collaboration. Proven ability to lead and mentor teams while managing external CDMO relationships and ensuring quality and timelines in a fast-paced environment.

Highest-signal resume keywords

Drug Product DevelopmentProcess ValidationCDMO ManagementRegulatory SubmissionsTechnical Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Formulation DevelopmentTechnology TransferScale-UpCGMP RequirementsICH Q8/Q9/Q10Risk-Based ValidationManufacturing InvestigationsCAPA DevelopmentChange ManagementStatistical Tools

Soft Skills

Analytical SkillsCommunication SkillsDecision-Making SkillsMentoringCross-Functional Team Leadership

Industry Keywords

Pharmaceutical SciencesChemical EngineeringCMCOSD ManufacturingCommercial ReadinessInspection PreparednessLifecycle ManagementPost-Approval Change ManagementQuality AssuranceVirtual Biotech Environment

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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