Merck · 5 months ago
Dir, Engineering, CMC Leader for Biologics
USA - New Jersey - Rahway
Full-time
Hybrid
Director/Executive
$170K/yr - $267K/yr
10+ years expMerck is a global healthcare company that is seeking a Director of Engineering and CMC Leader for Biologics. The role involves leading the Development and Commercialization Team to deliver a comprehensive CMC development strategy for the company's biologics portfolio, ensuring on-time execution of deliverables and effective communication across teams and stakeholders.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Responsible for on-time, end-to-end execution of DCT deliverables including – robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve uninterrupted long-term supply
Lead DCT. Critically assesses all team deliverables & fosters a learning and collaborative environment. Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen circumstances
Responsible to ensure the best science and most robust processes are used, working closely with DCRC. As the Product TPL takes ownership for the products’ technical processes and associated technical challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors. Conducts options analysis and provides recommendation to governance for endorsement
Represent CMC and effectively communicates across the governance bodies, stakeholders and teams. Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team’s strategy to ensure a robust CMC strategy is achieved. Identifies options to balance Speed/Cost/Robustness & achieve target commercial product. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product
Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions
Work collaboratively to drive a safe and compliant culture
Qualification
Required
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
Development and Commercialization Experience: Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing
Technical Depth and Breadth of Experience: Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes
Strategic Thinking/Enterprise Mindset: Understands and can articulate the 'Big' picture, thinks strategically, and demonstrates a customer orientation
Problem Solving and Innovative Thinking: Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate complex problems
Ability to Navigate Ambiguity: Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, and/or new information
Productive Communication: Plans and delivers ideas and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of the enterprise
Collaboration and Teamwork: Creates, leads, and sustains high performing teams, fostering an environment of open communication, enabling all team members to contribute their perspectives and collectively resolve issues
Drives Results through Accountability: Demonstrates effective leadership of team activities to ensure on-time, end-to-end project execution and delivery
Influence: Ability to persuade and inspire others to take action, make decisions, or change their attitudes and behaviors
Ownership: Exhibits a proactive mindset, a strong sense of initiative, and the willingness to take on challenges and see them through to completion
Preferred
Experience in ADC development and commercialization
Experience in Technical product stewardship
Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms
Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly
Expert knowledge in QbD
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
2026-01-23
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