Senior Specialist – Stability & Sample Management

MSD • Rahway, NJ

19h • Hybrid

About The Position

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our Research Laboratories Division is seeking applicants for a for a Senior Specialist position available at the Rahway, New Jersey research facility. The Stability and Sample Management Senior Specialist will work as a part of the integrated Stability Operations team and drive a culture of quality and operational excellence across the global analytical network. The Stability and Sample Management Senior Specialist will oversee and support GMP stability and sample management logistics in collaboration with our analytical scientists.

Requirements

• An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives.
• Proven track record of strong technical and innovative problem solving
• Desire and ability to learn new concepts outside of core expertise and training
• Excellent communication skills, demonstrated creativity, and effective interpersonal skills.
• Experience working within a GMP environment.
• Understanding of GMP policies and procedures.
• Related industry experience supporting management of analytical samples
• M.S. with 3+ years of post-degree relevant industry experience or B.S. with 7+ years of experience

Nice To Haves

• Demonstrated commitment to diversity and inclusion.
• Experience leading a team for a common goal.
• Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management.
• Experience supporting internal and external quality audits.
• Experience supporting logistical requirements for capital expansions including facility/ CTU requirements and capacity planning.

Responsibilities

• Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence.
• Receive analytical samples from partner groups according to established procedures.
• Aliquot, prepare, and label analytical samples for distribution to on-site testing laboratories or shipment, including the coordination of international shipments.
• Manage and maintain a suite of GMP stability chambers in a state of permanent inspection readiness.
• Provide technical supervision to a small group of specialists
• Manage analytical samples for pipeline stability studies.
• Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, Benchling, electronic notebook, eLogs).
• Stability study builds in LIMS and data management.
• Perform deviations and investigations, create Change Management records (where necessary), manage GMP documentation including Standard Operating Procedures (SOP).
• Support logistical requirements for capital expansions including facility/ CTU requirements and capacity planning.
• Continuous improvement to maintain state-of-the-art stability infrastructure to meet Global compliance standards.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees