Director, Small Molecule – Technical Product Leader

Jobtailor; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor is seeking a senior CMC leader to head the Development Commercialization Team (DCT), guiding late-stage drug candidates from development to launch and seamless supply.

You will drive an integrated, stage-appropriate commercialization strategy, lead cross-functional teams, manage risk, and ensure GMP compliance while collaborating with Value Chain Management to optimize lifecycle outcomes. Travel up to 10%.

Qualifications

• Bachelor’s degree in science or engineering with 10+ years of experience or advanced degree with 7+ years.
• 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 and risk management.
• No visa sponsorship available.
• 10% travel required.

Responsibilities

• Lead the Development Commercialization Team (DCT) and guide drug candidates from late development to launch and supply transition.
• Support Value Chain Management in realizing product lifecycle strategy.
• Deliver an integrated, stage-appropriate development and commercialization strategy to achieve the target product.
• Oversee on-time execution of DCT deliverables, including processes, analytics, and filing and approval.
• Represent CMC across governance bodies to drive decisions and outcomes.
• Balance speed, cost, and robustness to achieve the target commercial product.
• Create and lead high-performing teams and develop team members.

Skills

Cross-Functional Leadership

Regulatory CMC

GMP Compliance

Drug Product Manufacturing

Strategic Thinking

Decision Making

Risk Management

Stakeholder Engagement

Influencing

Driving Outcomes

Supply Chain

Manufacturing Scale-Up

Process Improvements

Product Management Leadership

Small Molecules

Education

Bachelor’s degree in science or engineering

Advanced degree

Job description

• 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

Requirements

• 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

Core Competencies

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

ATS Optimization Keywords

Hard Skills

• Drug Substance
• Drug Product
• Analytical
• Device
• Packaging
• Quality
• Supply Chain
• Manufacturing Scale-Up
• Process Improvements
• Product Management Leadership

Soft Skills

• Decision Making
• Risk Management
• Stakeholder Engagement
• Influencing
• Driving Outcomes

Industry Keywords

• CMC
• Commercialization Strategy
• Value Chain Management
• Tech Transfer
• Clinical Connectivity
• Small Molecules