Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Incumbent is fully accountable of Microbiology Laboratory operations including, but not limited to, analysis of raw materials, in-process and finished products, microbial identification, culture media preparation, stock culture maintenance, environmental monitoring, water testing/analysis programs and laboratory housekeeping/cleaning and the resolution of non conformance test result investigations. Provides the necessary technical and regulatory documentation direction, support and advice to the Microbiology Manager in terms of outstanding events or issues on a daily basis Provide mentorship to direct reports. Incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Responsibilities: 1. Supervises Microbiology Laboratory team facilitating and assuring compliance with policies and procedures, and enforces compliance with BMS policies, GMP, GLP and regulatory agencies such as FDA, EMA, WHO, ANVISA, COFEPRIS etc. 2. Drives laboratory operational performance by developing and retaining a robust talent pool, overseeing optimal training to develop their abilities, knowledge and skills to their maximum potential, which consistently delivers on established metrics, monitoring and improving per Quality standards, Operations Strategy and Operating Plan. Ensures that personnel attend all safety and GMP talks and any other mandatory training according to plant requirements. Supports and facilitates staff's active participation in site Initiatives and any other assignments based on business needs. 3. Provides timely coaching to ensures lab talent performance is as expected, performs daily lab walkthroughs and monitors analyst activities including EM in the manufacturing areas. 4. Provides support in performing microbiological and bioanalytical assays and equipment troubleshooting. 5. Author and approval of the following documents, as required: a. OOS and Quality Event Investigations and ensure timely closing, including CAPAs, within the required time frame and verifies that root cause and CAPA identified are based on a solid scientific rationale. b. APR reports and QC trend analysis 6. Identifies unusual microbiological test / trend results 7. Revises SOPs and ensures that 100% of personnel are trained prior to the effective date. 8. Leads and influences talent performance to guarantee & ensure that commitments are timely met. Provides necessary tools to analysts to facilitate problem solving within the required time frame. 9. Measures key performance indicators in area of responsibility. 10. Enforces the correct use of personnel protection equipment and compliance with BMS safety policies and OSHA. 11. Prepares section annual budget, provides headcount analysis as compared with projected hours and ensures that laboratory expenses are according to the approved budget. 12. Leads site/inter-site meetings as required. 13. Supports the Microbiology Laboratory in the absence of the Laboratory Manager, upon request. 14. Ensures staff compliance BMS Human Resources policies and procedures and directly contributes on hiring, developing, coaching, corrective / disciplinary actions, recognition, terminations and performance appraisal. 15. Develop mechanisms and a structure to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs. 16. Prepares CARs as required based on actual and future needs according to budget and provide required follow up. 17. Coordinates, evaluates and implement projects for area productivity. This includes the implementation of new laboratory equipment and methods. 18. Establishes short and long range plans for the timely and efficient execution of the microbiological testing activities within the scope of the business priorities and applicable regulatory requirements (FDA, OSHA, DEA, Police Department, etc). 19. Promotes and models the BMS Core Behaviors, facilitates teamwork, and maintains robust communication lines and feedback to management. 20. Establishes a system for disposition of raw materials, API's, finished products, packaging and labeling materials. 21. Ensure that Quality Control (QC) personnel is involved in testing of finished products, API's, biological drug substances, raw materials, intermediates / components have approved, validated methods and specifications, robust systems and adequate facilities to perform required testing. Ensure all necessary testing is carried out. 22. Uses results of testing performed in the Incoming Materials Area, Analytical and Microbiological laboratories for the disposition of products and / or raw materials. 23. Assures that stability studies performed at the site follow specific protocols and procedures. 24. Ensures that stability data supports the retest /expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies. • Ensures an effective process /system for disposition of raw materials, API's, packaging and labeling materials exist • Ensure that all QC personnel are qualified and trained in the applicable procedure required for their jobs functions. 25. Completes Annual Product Quality Review Report elements as established in products / systems schedule. 26. Verifies consistency with other site procedures and/or specifications. 27. Verifies compliance with BMS Policies and Guidelines. Knowledge/Skill: ? Bachelor Degree in Biology, Biotechnology, Medical Technology, Microbiology or Industrial Microbiology. ? Five (5) years of experience within a parenteral pharmaceutical industry as supervisor in a Quality Control Microbiology Laboratory. ? Knowledge and experience in parenteral products, aseptic manufacturing operations, environmental monitoring program, water sampling/testing, isolator technology, sanitation, sterilization and depyrogenation processes. ? Broad knowledge of GxPs, GLPs, EU, USP and FDA regulations and the ability to interpret and apply them. ? Familiarity with 21 CFR Part 11 and ALCOA principles ? A strong analytical skill is a must ? Self starter with strong analytical and self-management skills ? Strong Problem Solving Skills ? Knowledge of PCs (Words, Excel, Power Point) and in general microbiology laboratory instrumentation such as incubators, sterilizers, oven, scales, pH meters, air samplers, microscopes, Biohazard and Laminar Hoods. ? Excellent interpersonal skills and team work oriented, able to work under pressure. Builds and maintains strong relationships with team members, other functions, strategic partners and customers. ? Excellent communications skills in both English and Spanish ? Strong technical writing to support/author investigation reports ? Ability to plan work schedules and set priorities with urgency and meet deadlines within a complex, rapidly changing environment. ? Knowledge in environmental, health and safety matters as it relates to the site operation. ? Demonstrated competency in the resolution of issues and the improvement of systems. ? Willing to work irregular hours, rotating shifts, any day of the week and holidays, as necessary. 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 the resources to pursue their goals, both at work and in their personal lives.
