Bristol-Myers Squibb Company

Manager, Analytical Technical Services

Location
Manati, PR, United States
Posted
Sep 12, 2019
Ref
R1517549
Required Education
Bachelors Degree
Position Type
Full time
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:

Incumbent manages the Analytical Development, Technical Product's Transfer, all Analytical Technology Transfer and Analytical support for BMS-Manati site. 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. Supports Site QC objectives and goals. Ensures analytical laboratories technical support is consistent with departmental and site strategies, SOPs, Regulatory expectation and WWQ&C policies.
2. Manages assigned staff (hiring, training and development, discipline, performance connections etc.) ensuring training in appropriate procedures and protocols, including safety, cGMP's training, etc., and assures overall compliance with all accepted laboratory and safety procedures.
3. Supports functional area budget and participates in functional areas budget as needed.
4. Provides technical leadership and guidance to direct resources (staff) to insure timely completion of goals and objectives.
5. Prioritizes projects and determines resource constraints when necessary.
6. Validates analytical methodologies for marketed products as necessary.
7. Participates on project teams to ensure that laboratory representation is provided on technical issues.
8. Manages Analytical Technology transfers.
9. Assures that data and reports generated by direct reports are consistent and accurate.
10. Assures that existing laboratory methodology at the site is robust and that validation is maintained within BMS guidelines.
11. Builds collaboration and harmonization within the development and manufacturing network at BMS and with other BMS groups in R&D, Regulatory and Tech Ops on project issues.
12. Ensures that all activities are performed in compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, DEA, etc) and, ensures consistency with other site procedures and/or specifications and compliance with BMS Policies and Guidelines.

13. Maintains a safe work environment.
14. Interacts and supports in BOH inspections and regulatory submissions with regards analytical and technical/laboratory matters.
15. Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives.
16. Ensures that deviations from procedures and specifications are investigated, resolved and documented, that corrective / preventive actions are identified and implemented to avoid the occurrence / recurrence of deviations and that no materials are released before the completion of the investigation."
17. Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality/analytical issues in a timely fashion.
18. Ensures and facilitate that all laboratory personnel involved in testing of finished products, API's, biological drug substances, raw materials, intermediates/components have approved, validated methods and specifications, robust systems .
19. Assures that the QC equipment and personnel are formally qualified before release testing of products/materials is performed.
20. Completes Annual Product Quality Review Report elements as established in products / systems schedule.
21. Reviews supporting data for compliance with cGMP documentation practices.
22. Approves or reject procedures impacting the Analytical Technical group and in support to other QC laboratories functions.
23. Serves as a liaison with internal and external customers.
24. Provides technical guidance in the review for approval of specifications impacting drug products, and/or raw material.

Knowledge/Skill:

- Bachelor Degree of Science in Chemistry or related field.
- Minimum three (3) years of progressive managerial experience within the quality control function of the pharmaceutical/health care industry and regulatory agencies,
- Five 5 years experience in chemical, analytical laboratory within the aseptic filling and finishing areas for liquid and lyophilized products.
- In depth scientific knowledge related to analytical and chemical science.
- Knowledge in analytical instrumentation
- Excellent analytical and problem solving skills
- Strong leadership skills
- Proficient in cGMP's and FDA regulations and requirements.
- Excellent interpersonal skills
- Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management.
- Must be innovative and creative and utilize all available resources.
- Working knowledge in PC's and electronic tools.
- Excellent communication skills in both English and Spanish.

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.