Merck · 4 hours ago
Associate Director - Stability Operations
USA - Pennsylvania - West Point
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$129K/yr - $203K/yr
6+ years expMerck is seeking an Associate Director for its Stability Operations & Compliance department within the Research & Development Division. The role involves managing GMP stability studies and logistics for large molecule portfolios, while driving a culture of quality and operational excellence across the global network.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Participation in cross-functional teams for vaccines, biologics, and/or devices for the management of clinical and commercial GMP stability studies. This includes planning, coordination across internal and external networks, and implementation of stability studies for the large molecule portfolio, in accordance with applicable regulatory requirements
Responsible for managing 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; tracking stability metrics to ensure pull-on-time, test-on-time and review-on-time
Utilization of 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, leveraging digital systems (e.g., LIMS, electronic notebook, electronic document management systems)
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 devices
Support authoring regulatory source documents and stability sections
Change management: 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
Qualification
Required
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
Preferred
Experience with conducting stability facility gap analyses and developing solutions proactively
Sound scientific understanding of stability principles as they relate to data analysis and statistical models for predictive approaches to establish shelf life
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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