MSD

Senior Specialist, Stability Operations

MSD

full-time

Posted on:

Origin:  • 🇺🇸 United States • Pennsylvania

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Salary

💰 $104,200 - $163,900 per year

Job Level

Senior

Tech Stack

Spark

About the role

  • The Analytical Research & Development (AR&D) Stability Operations & Compliance department of our company Research Laboratories Division is seeking applicants for a stability operations senior specialist position available at the West Point, Pennsylvania research facility.
  • The Stability Operations Senior Specialist will work as a part of the integrated Stability Operations & Compliance team and drive a culture of quality and operational excellence across the global AR&D network.
  • The Stability Operations Senior Specialist will oversee and manage GMP stability studies and logistics for our large molecule portfolio in collaboration with our AR&D scientists.
  • The key responsibilities of this role will include: Management of GMP stability studies, including detailed planning, coordination across networks, and implementation of stability studies for the large molecule portfolio, in accordance with all applicable regulatory requirements.
  • Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for stability studies.
  • Evaluation of stability data, including statistical analysis and trending, investigating out of specification stability results, and communication with integrated project teams for biologics, vaccines, and/or devices.
  • Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, Benchling, electronic notebook, electronic document management systems).
  • Execute deviations and investigations, Change Management records, manage GMP documentation including stability protocols, Standard Operating Procedures (SOP), and GMP data management.
  • 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

  • M.S. in Chemistry, Biology, Engineering or related field with 3+ years of post-degree relevant industry experience
  • B.S. in Chemistry, Biology, Engineering or related field with 7+ years of experience
  • Knowledge and understanding of regulatory guidance and quality standards applicable to stability testing and shelf-life determination of vaccines and/or biologics.
  • Working knowledge of analytical methods and GMP policies and procedures.
  • Experience working within a GMP environment.
  • 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.
  • Related industry experiences supporting management of stability studies.