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Director, Molecule – Technical Product Leader
Job in
Elizabeth, Union County, New Jersey, 07215, USA
Listed on 2026-09-04
Listing for:
Jobtailor
Full Time
position Listed on 2026-09-04
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
- Lead the Development Commercialization Team (DCT) at Line of Sight to Commercial Product Definition
- Guide drug product candidates from late-stage development to launch and transition to supply
- Support the Value Chain Management Team (VCMT) in realization of product lifecycle strategy
- Deliver an integrated, stage-appropriate development and commercialization strategy to achieve the target commercial product
- Lead the cross-functional DCT, assess team deliverables, foster collaboration, and mitigate risks
- Oversee on-time execution of DCT deliverables, including processes and analytics, control strategy, tech transfer packages, filing and approval, and commercial supply chain
- Represent CMC across governance bodies, stakeholders, and teams to drive decisions and outcomes
- Influence and challenge xDT strategy to ensure a robust CMC strategy
- Balance speed, cost, and robustness to achieve the target commercial product
- Oversee VCMT deliverables, including new nodes and filings
- Create and lead high-performing teams and develop team members
- Bachelor’s degree in science or engineering related discipline with 10 or more years of experience, or an Advanced degree with 7 or more years of experience
- Technical depth and breadth in at least one CMC function
- Expertise across Drug Substance, Drug Product, Analytical, Device, Packaging, Regulatory, Quality, and Supply Chain
- Understanding of connectivity between clinical, CMC, and HH
- Cross-functional leadership
- Decision making and risk management
- Drug product manufacturing
- External manufacturing
- GMP compliance
- Manufacturing scale-up
- Process improvements
- Product management leadership
- Regulatory CMC
- Small molecules
- Stakeholder engagement
- Strategic thinking
- Supply chain
- Ability to lead complex discussions, influence stakeholders, and drive outcomes
- No visa sponsorship available
- 10% travel required
Demonstrates expertise in CMC functions, including Drug Substance, Drug Product, and Regulatory processes, while leading cross-functional teams to drive product commercialization and lifecycle strategies. Proven ability to manage risks, influence stakeholders, and ensure compliance with GMP standards.
Highest-signal resume keywords- Cross-Functional Leadership
- Regulatory CMC
- GMP Compliance
- Drug Product Manufacturing
- Strategic Thinking
- Drug Substance
- Drug Product
- Analytical
- Device
- Packaging
- Quality
- Supply Chain
- Manufacturing Scale-Up
- Process Improvements
- Product Management Leadership
- Decision Making
- Risk Management
- Stakeholder Engagement
- Influencing
- Driving Outcomes
- CMC
- Commercialization Strategy
- Value Chain Management
- Tech Transfer
- Clinical Connectivity
- Small Molecules
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