Associate Director - Stability Operations

MSD•Rahway, NJ

3d•Hybrid

About The Position

The Analytical Research & Development (AR&D) Stability Operations & Compliance department within our Research & Development Division is seeking applicants for a stability operations Associate Director position available at the Rahway NJ research facility. The Stability Operations Associate Director 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 Associate Director will oversee and manage end to end GMP stability studies and logistics for our large molecule portfolio. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. They are expected to be self-motivated and possess excellent communications skills in order to work effectively across intra- and inter-departmental boundaries. Evidence of strong cross-functional collaboration in an academic or industrial setting and a working knowledge of Good Practices (GxP) as it relates to stability study execution and documentation is expected. The candidate will also support the identification of internal and external stability sites and assess capabilities and capacity. The key responsibilities of this role will include: 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

Requirements

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.

Nice To Haves

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

Responsibilities

Participation in cross-functional teams for vaccines, biologics, and/or devices for the management of clinical and commercial GMP stability studies.
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