**Job Description**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**Education Minimum 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.**Required Experience and Skills**• 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**• 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#AR&D**Required Skills:**Biochemistry, Biochemistry, Biopharmaceutical Industry, Biopharmaceutics, Capillary Electrophoresis (CE), Clinical Data Interpretation, Clinical Judgment, Continuous Process Improvement, Creativity, Cross-Functional Collaboration, Data Monitoring, Detail-Oriented, Equipment Maintenance, Experimentation, GMP Compliance, Immunochemistry, Interdisciplinary Collaboration, International Regulatory Compliance, Laboratory Informatics, Laboratory Information Management System (LIMS), Laboratory Techniques, Leadership, Management Process, Metrology, Operations Management {+ 4 more}**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**US and Puerto Rico Residents Only:**Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and #J-18808-Ljbffr
if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and #J-18808-Ljbffr