Sr. Manager, Principal Scientist
New York City, New York
Expiry Date :
Sun, 07 Mar 2021 23:59:59 GMT
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Scope: The Scientist is responsible for method transfers, method improvement, remediation, method validation/verification and/or troubleshooting of commercial products (API and drug product) within Quality Control laboratories. Serves as a Subject Matter Expert interfacing with Regulatory Agencies and Contract Service Providers as a technical expert. The Scientist is responsible for investigating commercial product complaints/issues at all manufacturing sites, domestic, international and Contract Manufacturing Organizations. The position requires proficiency working with small molecules or biologics in oral dosage and/or sterile injectables. Required Competencies: – Advanced knowledge and interpretation of cGMP – Intermediate understanding of analytical validation and technical transfer concepts and requirements – Intermediate written and verbal communication skills – Intermediate problem-solving ability/mentality, technically adept and logical – Intermediate level interfacing with Regulatory Authorities and Contract Service Providers – Intermediate experience defending validation principles and processes in internal and external audits – Intermediate knowledge of international regulatory requirements (PIC/S, USP, Ph.Eur, JP, FDA (21CFR part 11, 210 and 211), Annex 11 (EU-GMP), ICH, and Good Automated Manufacturing Practice (GAMP) . – Basic ability to oversee external analytical service providers (i.e. raw data review, support service provider certification process) – Intermediate project management skills – Intermediate knowledge of laboratory and aseptic processes. – Ability to work independently, and/or lead and participate in team projects – Intermediate knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio – Requires presentation development and delivery skills. – Ability to gown and maintain a sterile work environment Duties and Responsibilities: – Perform Validation of Analytical Methods or Tech Transfer – Responsible for monitoring and managing the life cycle of assigned analytical methods. – Design and perform experiments to evaluate analytical methods associated with commercial products for feasibility, method improvement, remediation and/or troubleshooting. – Writes formal analytical documents such as validation protocols, method transfer protocols and investigations reports. – Conducts analytical method transfer to internal and/or external commercial manufacturing/testing facilities. – Evaluate and participate in the review and implementation of compendia changes with impact to analytical methods – Support Laboratory Investigations, deviations, CAPA’s, Change Controls – Ability to troubleshoot method and/or equipment issues to the root cause. – Capable of resolving non-routine laboratory issues and problems expeditiously – Interacts with CSPs, reviews raw data generated by CSPs and supports their lab investigations as needed. – Ability to write analytical method risk assessments or regulatory impact assessment statements (RIAS). – Participates in audits and interacts and answers questions from Heath Authorities – Support equipment, chemistry standards and controls – Participate in the selection/implementation of laboratory equipment and software – Participate in the management of global reference standards and controls (lifecycle for stability and routine usage) – Oversight of external Analytical Service Providers as appropriate – Support the approval and the qualification process – Review raw data (QC peer review) – Participate in the inspection/audit at Contract Service Providers – Provide support to Service Providers during Health Authority inspections – Performs general administrative and organizational activities – Subject Matter expert for internal/external audits – Develop strategies for method transfer and implementation for new products and excipients – Perform QC oversight of commercial CSPs – Acts as functional area expert – Maintain qualification status on aseptic gowning, sterility testing, BET Education and Experience – B.S./ M.S. in Chemistry or relevant discipline with minimum of 7 years of relevant work experience – Ph.D. in Chemistry or relevant discipline with minimum of 4 years of relevant work experience. – An equivalent combination of education and experience may substitute BMS/BL Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.