Hybrid Associate Director – Stability Operations

at MSD

• Job title: Associate Director – Stability Operations
• Job type: Full Time
• Experience level: Senior
• Salary: $129,000 - $203,100 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Associate Director managing GMP stability studies and logistics for large molecule portfolio. Collaborating with integrated teams and driving operational excellence in stability operations.

Responsibilities

• 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

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