SENIOR SCIENTIST I Job
Job Code - 36947
Job First Active on: Thursday, February 23, 2012
SENIOR SCIENTIST I
Global Analytical Technology (GAT) is a function within the Worldwide Quality and Compliance (WWQC) organization of the Bristol-Myers Squibb Technical Operations division. GAT provides headquarters subject matter expertise in areas of analytical method development and innovation, transfer of analytical methodology, and representation on cross-functional teams that address new product introductions, supply chain strategy, and product surety. GAT supports the manufacturing network in the areas of product transfers, investigations, technical review and assistance, and maintenance of the reference standards program.
Major Duties and Responsibilities
1. Participate in cross-functional teams as the analytical subject matter expert representing the interests of Technical Operations, e.g., in the areas of new and mature product analytical development and investigations, forensics analytical support, transfer of analytical technology, etc. 2. Design studies for the development and validation of analytical methods. Conduct laboratory studies and experiments. 3. Review and approve change control documents and review compendial monographs. 4. Evaluate and apply new analytical technologies to address Product Surety and productivity in the Quality Control Laboratory. 5. Manage technical transfers of analytical methods including; review and approve data for accuracy and agreement with acceptance criteria; investigate and resolve discrepancies. 6. Resolve questions/ troubleshoot analytical techniques, procedures and validation requirements from BMS sites and third parties. 7. Review method validation documentation to determine compliance with ICH requirements and manage remediation of gap analysis at TPM or in BMS laboratories. 8. Prepare /review and serve as subject matter expert for departmental SOP's. 9. Provide technical and documentation support for the Reference Standards Group. 10. And other Duties as defined.
REQUIREMENTS - QUALIFICATIONS: SENIOR SCIENTIST I
Requirements and Expected Areas of Competence: 1. BA/BS in science with at least 5-7 years; or MS in science with 4-6 years; or Ph.D. with at least 2 years of relevant pharmaceutical experience. Experience in technical operations (manufacturing division) a plus. 2. Strong written, verbal, and interpersonal communication skills to clearly communicate scientific objectives and project results. 3. Overall awareness of the pharmaceutical manufacturing and quality processes and regulatory requirements necessary for the manufacture and distribution of pharmaceutical products. 4. Exhibits a thorough understanding of analytical chemistry and its application using modern analytical instrumentation. Monitors new developments and trends in own scientific/technical area. 5. Strong analytical and problem solving skills, especially related to analytical chemistry and application in method implementation, development, and/or validation. 6. Understands relevant regulatory requirements (GXP) and company standard operating procedures. Actively ensures others also understand appropriate regulations. 7. Demonstrates good judgment when information/opinions are communicated to others. Accurately and effectively communicates (written and verbal) position and information to peers, supervisor, teams, and external contacts which may have a tangible effect on the perception of the department and Technical Operations. 8. Actively promotes own learning and influences knowledge and training of others.
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