Biologics CMC & DCT Strategy Lead (Early-Stage)

Merck; New Jersey; Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Merck in Rahway, New Jersey, seeks a scientific leader to direct strategy and execution of biologics drug substance programs. This individual will oversee CMC program leadership, scale-up, tech transfer, and clinical manufacturing for early development through FIH milestones.

The role requires depth in cell line development, upstream/downstream processing, and regulatory strategy, with a proven ability to align cross-functional teams and deliver compliant, scalable solutions.

Formación

• PhD in a relevant field with 8+ years biopharmaceutical experience.
• MS with 10+ years biopharma experience.
• BS with 14+ years biopharma experience.
• Demonstrated integrated CMC and matrix leadership across multiple functional groups.
• Experience with cell line, upstream and downstream process development and tech transfer.

Responsabilidades

• Lead cross-functional DCTs with integrated CMC strategy and governance.
• Establish and manage matrixed CMC teams with clear accountability.
• Align strategy across drug substance, analytics, regulatory, quality, and manufacturing.
• Identify risks, propose data-driven contingencies, and report to senior leaders.
• Drive continuous improvement and scalable processes for early clinical to commercialization.

Conocimientos

Integrated CMC leadership

Matrix leadership

Biologics development

Regulatory strategy

Cross-functional collaboration

Risk management

Educación

Ph.D. in a related discipline

M.S. in a related discipline

B.S. in a related discipline

Descripción del empleo

Merck in Rahway, New Jersey, seeks a scientific leader to direct strategy and execution of biologics drug substance programs. This individual will oversee CMC program leadership, scale-up, tech transfer, and clinical manufacturing for early development through FIH milestones.

The role requires depth in cell line development, upstream/downstream processing, and regulatory strategy, with a proven ability to align cross-functional teams and deliver compliant, scalable solutions.