Early-Stage DCT Lead & Biologics Analytics Leader

Merck & Co.; Rahway (NJ); In loco; USD 157.000 - 247.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in Rahway, NJ is seeking an Early-Stage DCT Leader to guide integrated CMC teams for pipeline biologics from candidate selection through early clinical development and FIH milestones.

The role combines strategic direction, analytical SME work, and cross-functional leadership to ensure robust characterization, CQAs assessment, and phase-appropriate control strategies, enabling swift progression to first-in-human studies.

Competenze

• . PhD/MS/BS with required years of biopharmaceutical experience.
• . Demonstrated leadership in integrated CMC and matrix program leadership.
• . Deep expertise in biologics analytical development and method qualification/validation.
• . Experience with regulatory filings and risk-based decision making.

Mansioni

• Lead integrated CMC program leadership for pipeline biologics.
• Define analytical control strategies and product characterization workflows.
• Guide regulatory filings and ATRs for analytical sections.
• Mentor junior scientists and foster an inclusive team culture.
• Drive cross-functional governance and risk management.

Conoscenze

Analytical Method Development

Analytical Thinking

Assay Development

Bioanalytical Analysis

Biopharmaceuticals

Biotechnology

Chromatographic Techniques

Mass Spectrometry

CD

DSC

Formazione

Ph.D.

M.S.

B.S.

Strumenti

U/HPLC

SEC

IEX

HIC

RP

CE-SDS

cIEF

Mass spectrometry

Intact mass

Peptide mapping

PTMs

ELISA

SPR

Cell-based assays

Descrizione del lavoro

Merck & Co. in Rahway, NJ is seeking an Early-Stage DCT Leader to guide integrated CMC teams for pipeline biologics from candidate selection through early clinical development and FIH milestones.

The role combines strategic direction, analytical SME work, and cross-functional leadership to ensure robust characterization, CQAs assessment, and phase-appropriate control strategies, enabling swift progression to first-in-human studies.