Stability Operations Director — Pharma Analysis & Digital Tech

Merck

Rahway (NJ)

Hybrid

USD 173,000 - 273,000

Full time

16 hours ago

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Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in Rahway, NJ seeks a Director of Stability Operations to lead an integrated stability organization across biologics, vaccines, and small molecules. You will drive end-to-end stability strategies, partner with cross-functional teams, and ensure readiness for regulatory submissions.

The role emphasizes people development, governance, and digital modernization of stability workflows, with a broad scope across development and manufacturing interfaces. Hybrid work arrangements are available.

Qualifications

Experience designing clinical stability study strategies for Biologics, Vaccines, or Small Molecule programs.
Knowledge of global stability regulations and expectations (ICH, FDA, EMA, CMC).
Experience guiding assets across clinical-to-commercial boundary (late-stage development to filings).
Leadership in cross-functional, matrixed forums with influence across multiple functions.
Experience applying quality, deviation management, and inspection readiness in GxP environments.

Responsibilities

Provide strategic, scientific, and operational leadership for end-to-end Stability Operations across biologics, vaccines, and small molecules.
Lead stability studies planning, execution, monitoring, and governance across development pipeline.
Partner with development teams, External Capabilities, Quality, and program teams to identify stability risks.
Clarify stability-facing roles and governance across internal/external groups.
Establish cross-divisional forums to ensure smooth stability transitions (validation, PPQ, launch).
Oversee stability content for IND, IMPD, NDA, and BLA filings and data presentation.