Stability Ops Director – Pharma Analytics & Digital Tech

Merck & Co.; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement benefits

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck & Co. seeks a Director of Stability Operations in the Pharmaceutical Analysis and Digital Technologies (PADT) to lead an integrated stability organization across biologics, vaccines, and small molecules.

You will guide strategies enabling uninterrupted clinical supply and regulatory submissions while preparing for commercial transitions. The role requires building a unified operating model, governance across internal and external partners, and modernization of stability data workflows,

Qualifications

• Ph.D. or MS/BS with extensive experience in stability operations for biologics, vaccines, or small molecules.
• Experience designing stability study strategies and regulatory support.
• Strong cross-functional leadership across R&D and manufacturing.
• Proven ability to influence stakeholders in a matrixed organization.

Responsibilities

• Provide strategic leadership for end-to-end stability operations across modalities.
• Lead stability study planning, execution, monitoring, and data readiness.
• Define governance and ownership across internal/external groups.
• Drive digital modernization including RLIMS2 and automated reporting.
• Ensure compliance with QMS, safety, and inspection readiness.
• Manage a team of ~25 and develop future leaders.

Skills

Analytical Chemistry

Analytical Functions

Analytical Method Development

Biologics

Biologics License Application (BLA)

Chemistry

Chromatographic Techniques

Drug Development

Non-Disclosure Agreements

Operational Quality

People Leadership

Pharmaceutical Sciences

Pharmaceutics

Process Analytical Technology (PAT)

Regulatory Compliance

Regulatory Submissions

Results-Oriented

Scientific Analysis

Stability Studies

Standards Compliance

Talent Development

Team Leadership

Education

Ph.D. in Chemistry/Pharmaceutical Sciences/Biochemistry/Biology/Chemical Engineering or related

MS degree with 12+ years of relevant experience

BS degree with 14+ years of relevant experience

Tools

RLIMS2

Benchling

Signals

GLIMS

Automated data pipelines

Regulatory authoring systems

Job description

Merck & Co. seeks a Director of Stability Operations in the Pharmaceutical Analysis and Digital Technologies (PADT) to lead an integrated stability organization across biologics, vaccines, and small molecules.

You will guide strategies enabling uninterrupted clinical supply and regulatory submissions while preparing for commercial transitions. The role requires building a unified operating model, governance across internal and external partners, and modernization of stability data workflows,