Provide administrative support for clinical functions and billing at Bradford County Health Department. Interview clients for economic eligibility and manage patient records and appointments.
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
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