Microbiology Technical Support Specialist

Profile

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.

Summary:

Accountable for the development and transfer of microbiological methodology, technical products transfer support. Supports the transfer/optimization of test methods, evaluation and closing of Change Controls, Corrective Actions Preventive Actions (CAPAs) according to BMS procedures and policies to ensure that procedures in the laboratory comply with BMS policies. Supports Operational Excellence initiatives within the Microbiology laboratory. This position must comply with all security guidelines, Environmental health and safety regulations and the current Good manufacturing Practices required by the job function.

Responsibilities:

Originates and implements QC Micro / MTS Laboratory Change Controls following BMS procedures and policies ensuring the accuracy of the information and closing within the established time frame. 2. Originates and implements corrective and preventive actions (CAPAs) following BMS procedures and policies and closing them within the established time frame. 3. Supports different Operational Excellence initiatives in the MTS Laboratory such as visual aids, 5’S, spaghetti diagram, standardize work, etc . 4. Supports the Safety Program within the MTS laboratories performing monthly audits and Job Hazard assessments. 5. Executes monthly area audits ensuring compliance with BMS procedures and policies. 6. Conducts Laboratory Investigations ensuring the identification of the root cause and corrective and preventive action to prevent re-occurrence 7. Supports MTS laboratories area metrics. 8. Recommends and makes changes to documents (e.g. SOP’s, protocols, Testing Standard, methods, monographs, etc.) and ensures that these documents are aligned with the cGMP practice and BMS policies and; verifies and ensures consistency with other sites procedures and/or specifications. 9. Provides training to new members on approved methods and procedures following applicable training SOP.10. Performs special projects. 11. Determines requirements for documentation, materials, trainings and equipment modifications within the laboratories during the new product introduction process.12. Generates protocols, reports, technical assessments and technical memos.13. Designs, evaluates, and executes Microbiology Method Transfer protocols. 14. Supports MTS special projects to accomplish company goals and objectives on a timely and effective manner15. Evaluates Microbiology methods deviations with respect to their causes and corrective actions to prevent recurrence. 16. Evaluates and appraises method and instrument changes in regards to regulatory requirements. Keeps current with emerging technologies, new instrumentation, and regulatory expectations relative to the pharmaceutical manufacture laboratory operations.17. Provides direct support for technology transfers to guarantee flawless execution to and from site.18. Generates and review scientific data and reports and ensures consistency and accuracy.19. Ensures that existing Microbiological methodology at the site is robust and that validation is maintained within BMS guidelines.20. Ensures that all activities are performed in compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, DEA, etc).

Knowledge/Skill:

• Bachelor Degree in Natural Sciences or Engineering• Minimum five (5) years of experience in Microbiology lab with at least two (2) years’ experience with the Aseptic Processing field.• Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply them • Ability to communicate effectively with wide range of personnel, written and verbal.• Strong technical writing and interpretation skills related to investigations and Regulatory Filings.• Extensive knowledge with the use and interpretation of pharmacopeias such as USP/NF, EP, JP, British.• Ability to create /organize cGMP systems and procedures based on regulatory compliance skills.• Experience with microbiology techniques such as isolator technology and aseptic processing techniques.• Knowledge and experience of computer and appropriate software packages (e.g., word processing, spreadsheets, communications like e-mail, LIMS, etc.).• Knowledge to collect and document data and /or other information (e.g. significant figures, rounding off rules, etc.).• Knowledge of computers applications (Microsoft Word, Excel, Power Point).• Excellent interpersonal skills and teamwork oriented.• Excellent communications skills in Spanish/English.• Knowledge of statistical tools.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com