Specialist – Stability & Sample Management

MSD • Upper Gwynedd Township, PA

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 specialist position available at the Rahway, New Jersey research facility. The Sample Management 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 Sample Management Specialist will oversee and support GMP stability and sample management logistics in collaboration with our analytical scientists. The key responsibilities of this role will include: 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 analytical samples for large molecule 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). Candidates should be able to function independently and be able to collaborate in a dynamic, integrated, multidisciplinary team environment. Effective communication skills, eagerness to adapt and learn, and a desire to conduct research and influence the field are essential attributes. As a member of our team, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

Requirements

• Bachelor’s degree, or higher, in analytical chemistry or related field with 3+ years post-degree relevant industry experience.
• 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

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.

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 analytical samples for large molecule 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).

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
• annual bonus
• long-term incentive

What This Job Offers

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