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Merck · 14 hours ago

Dir, Engineering, CMC Leader for Biologics

Rahway, NJ

Full-time

Hybrid

Director/Executive

$170K/yr - $267K/yr

10+ years exp

Merck is a leading pharmaceutical company seeking a Development and Commercialization Team leader for their biologics portfolio. The DCT leader will be responsible for executing a comprehensive CMC development strategy and ensuring the successful advancement of products through effective communication and collaboration across teams.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

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

DevelopmentCommercializationRegulatory RequirementsProduct ManagementTechnical LeadershipGMP ComplianceStakeholder EngagementCross-Functional LeadershipProblem SolvingCommunication StrategyInnovationCollaborationResults-OrientedOwnership

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

Applied Engineering

Capital Management

Change Management

Chemical Process Development

Communication Strategy Development

Cross-Cultural Awareness

Cross-Functional Leadership

Decision Making

Drug Development

External Manufacturing

GMP Compliance

Innovation