Director, Biologics Development – Commercialization Team Lead

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

Job summary

Jobtailor seeks an senior CMC strategy leader to deliver an integrated development and commercialization approach across the biologics portfolio. You will drive end-to-end DCT deliverables, assess team outputs, and balance speed, cost and robustness to achieve target commercial products.

The role leverages strong leadership and cross-functional collaboration across governance bodies. Candidates should have a BS/MS/PhD with extensive experience in CMC and product management systems, plus proven

Qualifications

• BS/MS/PhD with extensive experience in CMC development and commercialization leadership.
• Minimum 10+ years for PhD, 12+ for MS, 15+ for BS in relevant fields.
• Strong cross-divisional networking and enterprise leadership capabilities.
• Ability to influence at all levels and work strategically with management.

Responsibilities

• Deliver a fully integrated stage-appropriate CMC development and commercialization strategy.
• Advance the company's biologics portfolio.
• Responsible for on-time, end-to-end execution of DCT deliverables.
• Lead DCT and critically assess all team deliverables.
• Prioritize, interrogate and mitigate risks across factors impacting success or timelines.
• Analyze and develop innovative solutions.
• Ensure the best science and robust processes are used.
• Conduct options analysis and provide governance-ready recommendations.
• Represent CMC and communicate across governance bodies and stakeholders.
• Drive outcomes/decisions through influence, advocacy, and negotiation with stakeholders.
• Identify options to balance speed, cost, robustness and achieve target commercial product.

Skills

CMC Development Strategy

Cross Divisional Networking

Product Management Systems

Enterprise Leadership

Stakeholder Communication

Options Analysis

Risk Mitigation

Innovative Solution Development

Program Management

Collaborative Skills

Influencing Skills

Detail-Oriented Framework

Advocacy

Negotiation

Education

Bachelor of Science (BS)

Master of Science (MS)

PhD

Job description

• Deliver a fully integrated stage-appropriate CMC development and commercialization strategy
• Advance the company's biologics portfolio
• Responsible for on-time, end-to-end execution of DCT deliverables
• Lead DCT and critically assess all team deliverables
• Prioritize, interrogate and mitigate risks across all factors impacting success or timelines
• Analyze and develop innovative solutions
• Ensure the best science and robust processes are used
• Conduct options analysis and provide recommendations to governance
• Represent CMC and effectively communicate across governance bodies, stakeholders and teams
• Drive outcomes/decisions through influence, advocacy, & negotiation with stakeholders
• Identify options to balance speed, cost, robustness & achieve target commercial product

Requirements

• Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant experience, or Master of Science (MS) Degree with twelve (12) years of relevant experience, or PhD with ten (10) years relevant experience
• Strong cross divisional networking skills and capabilities
• Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization
• Strong collaborative skills and the ability to work strategically and in a detail-oriented framework with all levels of management
• Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment

Core Competencies

Demonstrates expertise in CMC development and commercialization strategies, with a strong focus on risk mitigation, stakeholder communication, and innovative problem-solving. Proven ability to lead cross-functional teams and manage multiple programs effectively while ensuring alignment with business objectives.

Highest-signal resume keywords

• CMC Development Strategy
• Cross Divisional Networking
• Product Management Systems
• Enterprise Leadership
• Stakeholder Communication

ATS Optimization Keywords

Hard Skills

• Biologics Portfolio Management
• Options Analysis
• Risk Mitigation
• Innovative Solution Development
• Program Management

Soft Skills

• Collaborative Skills
• Influencing Skills
• Detail-Oriented Framework
• Advocacy
• Negotiation

Certifications & Qualifications

• Bachelor of Science (BS)
• Master of Science (MS)
• PhD

Industry Keywords

• DCT Deliverables
• Governance Bodies
• High-Performance Work Environment
• Commercial Product Target
• Business and Financial Skills