Quality Control Senior Supervisor 3rd Shift

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:

Supervise and coordinate all activities of the Bio-analytical laboratory in order to assure the optimum utilization of laboratory resources equipment and personnel for the timely and efficient testing / release of components, raw materials and finished products in compliance with the regulatory requirements to support company goals and objectives. 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:1. Establishes short and long range plans for the timely and efficient execution of the analytical testing activities within the scope of the business priorities and applicable regulatory requirements (FDA, DEA, OSHA, Police Department, PR Chemical Association).2. Develops mechanisms and structures to allow for adjustment in the laboratory testing schedule to meet changing priorities due to business needs.3. Implements systems to lead, guide and motivate the personnel under his / her responsibility to perform at the maximum potential. 4. Encourages and facilitates the willingness to accept more responsibilities to develop their potential to a greater degree.5. Performs timely and effective staffing related activities including, but not limited to the requirements of the Human Resources policies and procedures, hiring / termination, recognition / disciplinary actions, performance appraisals and; assures that all Bio analytical personnel are qualified and trained in the applicable procedure required for their jobs functions.6. Fosters cycle time reduction initiatives within the scope of the Continuous Innovation approach.7. Ensures that the laboratory operates within the budget commitments.8. Reviews and makes disposition of laboratory records ensuring that the analytical data complies with requirements / specifications.9. Identifies, unusual analytical test results / trends. Conduct trend analysis.10. Consults R & D, Analytical Development Group and other departments for resolution of technical and operational issues.11. Communicates with internal and external customers.12. Coordinates samples testing and analytical reports disposition.13. Designs experiments (where applicable) as part of laboratory investigations.14. Organizes and plan individual and collective work.15. Assures completion of investigations and completeness of analytical data for lots / materials disposition.16. Anticipates problems / situations and develop plans to prevent or minimize impact. Use internal and multifunctional teams, as appropriate.17. Uses the technical knowledge and experience from self and team members to systematically gather and analyze data in an efficient manner to draw logical conclusions. Exercise analytical and strategic thinking.

Assists the Analytical Labs Manager in the administration of:a. Budgetb. Lab. Performance Metricsc. Lab. Supplies inventoriesd. Report CAR’se. Company initiatives / special projectsf. Foster leadership, growth and continuous innovation initiatives at all levels. 19. Establishes and ensures and effective process / system for disposition of raw materials, API’s, finished products, packaging and labeling materials.20. Ensures that all Quality Control (QC) personnel 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.21. Assures that the QC equipment and personnel are formally qualified before release testing of products/materials is performed.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.25. Ensures the functional area has an effective process /system for disposition of raw materials, API’s, packaging and labeling materials.26. Completes functional Annual Product Quality Review Report elements as established in products / systems schedule.27. Ensures that the functional area has an effective process in place for reserve sample collection and storage.28. Verifies consistency with other site procedures and/or specifications.29. Verifies compliance with BMS Policies and Guidelines.

Knowledge/Skill:

BS in Biochemistry or Chemistry

5 years of supervisory experience within the Analytical laboratory in the pharmaceutical industry

Experience with bio-analytical techniques as SDS PAGE, IEF, SEC, ELISA, CE, cell culture, bioassays, etc.

Experience with analytical techniques as HPLC, GC, UV, IR, etc. preferable

Deep technical knowledge of proteins and bio-molecules handling and analysis.

Active in PR Chemical Association License is required.

Excellent Communication skills – English / Spanish (oral and written).

Proficient in the use of financial and quantitative information to develop realistic budgets and central operational expenses.

Posses up to date knowledge in the profession and industry.

Strong knowledge in fundamental, practical and theoretical understanding of biochemistry.

Working knowledge of business, PCs and related softwares.

Proficiency in troubleshooting laboratory equipment and analytical and bio-analytical methods.

In depth knowledge of compendia applicable to pharmaceutical analytical methods.

Knowledge of EHS policies, procedures and regulatory requirements.

Knowledge of the regulatory requirements governing the functions of the analytical testing laboratory for pharmaceutical products.

Knowledge of applicable testing compendia (foreign / domestic).

Practical knowledge of laboratory instrumentation (HPLC’s, UV’s, GC’s, FTIR, AA, NIR)

Accomplishments in the areas of innovation, teamwork, personnel and leadership development, customer services.

Understanding of the business from the local and global perspective.

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