MSD

Associate Director – Stability Operations

MSD

full-time

Posted on:

Location Type: Hybrid

Location: Rahway • New Jersey • Pennsylvania • United States

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Salary

💰 $129,000 - $203,100 per year

Job Level

Senior

About the role

  • 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
  • oversee and manage end to end GMP stability studies and logistics for our large molecule portfolio
  • collaborate in a fast-paced, integrated, multidisciplinary team environment
  • support the identification of internal and external stability sites and assess capabilities and capacity
  • participate in cross-functional teams for vaccines, biologics, and/or devices for the management of clinical and commercial GMP stability studies
  • plan, coordinate across internal and external networks, and implement stability studies for the large molecule portfolio
  • manage GMP documentation including stability protocols, Standard Operating Procedures (SOP), Re-evaluation dating memo, Stability reports and GMP data
  • successful collaboration with internal and external parties to ensure implementation and execution of stability studies
  • ensure coordination with stability staging and testing laboratories for efficient sample and data management
  • track stability metrics to ensure pull-on-time, test-on-time and review-on-time
  • utilize Digital applications (such as Electronic Data Management Systems, Laboratory Information Management System) for stability study builds and data management
  • support second person review requirements to ensure accuracy, compliance, integrity, completeness, and traceability of stability documentation
  • maintain accurate records including sample inventory and sample chain of custody
  • evaluate stability data, including statistical analysis and trending, investigating out-of-specification stability results
  • communicate with integrated project teams for biologics, vaccines, and devices
  • support authoring regulatory source documents and stability sections
  • support re-evaluation dating and associated change controls, address stability-related deviations and investigations, maintain change management records and GMP documentation
  • 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

Requirements

  • Ph.D. with 2 years of experience, a Master’s degree with a minimum of 6 years of experience, or Bachelor’s degree in Chemistry, Biochemistry, Biology, Engineering or other pharmaceutically related field, with 10+ 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 method procedures routinely used in analysis of biologics and vaccines (e.g. capillary electrophoresis, HPLC, ELISA etc.)
  • Related industry experience supporting management of stability studies, including capacity planning and CTU maintenance
  • Working knowledge of Good Manufacturing Practice (GMP) compliance with regards to laboratory experimentation and documentation
  • Ability to identify out of specification/ trends in stability results, and actively participate on cross-functional investigation teams to determine root cause and corrective actions
  • Experience with digital platforms for stability studies including data management, trending, visualization and consistent documentation
  • Experience authoring and reviewing regulatory submissions and Health Authorities interactions (IND, IMPD and/ or marketing applications)
  • Demonstrated ability to assimilate and analyze large data sets to assess stability trends, and experience with advanced data visualization techniques
  • Ability to deliver under aggressive timelines in a rapidly changing environment
  • Individual leader capable of taking initiative for creative and innovative problem solving
  • A strong team player with effective oral and written and communication skills with the ability to work in matrix teams
  • Change champion with a desire and ability to learn new concepts outside of core expertise and training.
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
GMP compliancestability studiesanalytical method procedurescapillary electrophoresisHPLCELISAstatistical analysisdata visualizationregulatory submissionsshelf-life determination
Soft Skills
problem solvingteam collaborationcommunicationinitiativechange managementdata analysisadaptabilityleadershiptime managementcross-functional teamwork