Lead DCT activities, assess risks, and prioritize actions across technical, regulatory, and operational factors while fostering a collaborative, learning-focused environment.
Ensure alignment with product ownership and governance, delivering robust technical solutions and engaging in governance endorsements.
Represent CMC to governance bodies and stakeholders, influencing strategy to balance speed, cost, and robustness for the target product.
Direct technical reviews and ensure cross-functional teams develop robust solutions; maintain cGMP compliance and a culture of safety.
Collaborate across DS, DP, device, packaging, analytics, regulatory, quality, and supply chain to connect development with commercial manufacturing from early stages through launch.

Jobs at Merck & Co., Inc.

3 active roles from this employer in the JobMatcher catalog.

All company jobs

About the role

Position: Director of Biologics Development and Commercialization – CMC Team Lead Overview: The Development and Commercialization Team (DCT) leader is accountable for delivering a fully integrated, stage-appropriate CMC development and commercialization strategy for the biologics portfolio. The role leads the DCT to ensure on-time, end-to-end execution of deliverables, including robust analytical processes, an integrated control strategy, successful tech transfer packages, regulatory filings, and a reliable commercial supply chain to achieve uninterrupted long-term supply.

Responsibilities

Lead DCT activities, assess risks, and prioritize actions across technical, regulatory, and operational factors while fostering a collaborative, learning-focused environment.
Ensure alignment with product ownership and governance, delivering robust technical solutions and engaging in governance endorsements.
Represent CMC to governance bodies and stakeholders, influencing strategy to balance speed, cost, and robustness for the target product.
Direct technical reviews and ensure cross-functional teams develop robust solutions; maintain cGMP compliance and a culture of safety.
Collaborate across DS, DP, device, packaging, analytics, regulatory, quality, and supply chain to connect development with commercial manufacturing from early stages through launch.
Demonstrate strategic thinking and communication skills to lead complex discussions and drive outcomes with diverse audiences.
Build and sustain high-performing teams, fos

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Key requirements

Lead DCT activities, assess risks, and prioritize actions across technical, regulatory, and operational factors while fostering a collaborative, learning-focused environment.
Ensure alignment with product ownership and governance, delivering robust technical solutions and engaging in governance endorsements.
Represent CMC to governance bodies and stakeholders, influencing strategy to balance speed, cost, and robustness for the target product.
Direct technical reviews and ensure cross-functional teams develop robust solutions; maintain cGMP compliance and a culture of safety.
Collaborate across DS, DP, device, packaging, analytics, regulatory, quality, and supply chain to connect development with commercial manufacturing from early stages through launch.

Jobs at Merck & Co., Inc.

3 active roles from this employer in the JobMatcher catalog.

All company jobs

About the role

Position: Director of Biologics Development and Commercialization – CMC Team Lead Overview: The Development and Commercialization Team (DCT) leader is accountable for delivering a fully integrated, stage-appropriate CMC development and commercialization strategy for the biologics portfolio. The role leads the DCT to ensure on-time, end-to-end execution of deliverables, including robust analytical processes, an integrated control strategy, successful tech transfer packages, regulatory filings, and a reliable commercial supply chain to achieve uninterrupted long-term supply.

Responsibilities

Lead DCT activities, assess risks, and prioritize actions across technical, regulatory, and operational factors while fostering a collaborative, learning-focused environment.
Ensure alignment with product ownership and governance, delivering robust technical solutions and engaging in governance endorsements.
Represent CMC to governance bodies and stakeholders, influencing strategy to balance speed, cost, and robustness for the target product.
Direct technical reviews and ensure cross-functional teams develop robust solutions; maintain cGMP compliance and a culture of safety.
Collaborate across DS, DP, device, packaging, analytics, regulatory, quality, and supply chain to connect development with commercial manufacturing from early stages through launch.
Demonstrate strategic thinking and communication skills to lead complex discussions and drive outcomes with diverse audiences.
Build and sustain high-performing teams, fos

Track similar jobs

Get email alerts when new roles like this are posted.

Based on: Director of Biologics Development and Commercialization (CMC

See how this role matches your resume

Sign in to get an AI match score and personalized feed.

Create account Sign in

More in Hybrid

Engineering Fintech Remote Europe Remote-first Startups

Jobs at Merck & Co., Inc.

3 active roles from this employer in the JobMatcher catalog.

All company jobs

More in Hybrid

Engineering Fintech Remote Europe Remote-first Startups

Jobs at Merck & Co., Inc.

3 active roles from this employer in the JobMatcher catalog.

All company jobs

More in Hybrid

Engineering Fintech Remote Europe Remote-first Startups

Director of Biologics Development and Commercialization (CMC

Director of Biologics Development and Commercialization (CMC

Key requirements

Jobs at Merck & Co., Inc.

About the role

Responsibilities

Jobs like this

Key requirements

Jobs at Merck & Co., Inc.

About the role

Responsibilities

Jobs like this

Jobs at Merck & Co., Inc.

Jobs like this

Jobs at Merck & Co., Inc.

Jobs like this