Manager, Microbiology Laboratory

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

***3rd Shift-10:00pm.- 6:30am.***

MAJOR DUTIES AND 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.

3.Ensures that personnel attend safety and GMP talks and any mandatory training according to plant requirements. Supports and facilitates staff’s active participation in site Initiatives and any other assignments based on business needs.

4.Enforces the correct use of personnel protection equipment and compliance with BMS safety policies and OSHA.

5. Promotes and models the BMS Core Behaviors, facilitates teamwork, and maintains robust communication lines and feedback to management.

6.Provides timely coaching to ensures lab talent performance is as expected, manages performance of the team, performs daily lab walkthroughs and monitors analyst activities including EM in the manufacturing areas. Purposeful presence on the floor is expected to facilitate work and to identify continuous improvement to processes and the operation.

7.Provides support in performing microbiological assays and equipment troubleshooting if needed.

8.Authors, reviews, and/or approves documents, as required but not limited to:

a. OOS and Quality Event Investigations and ensure timely closing, including CAPAs, within the required time frame and verifies that root cause and CAPA records identified are based on a solid scientific rationale.

b. APR reports and QC trend analysis

9.Evaluates data to identify unusual microbiological test / trend results

10.Revises SOPs and ensures that 100% of personnel are trained prior to the effective date. Assigns tasks to trained personnel and ensures area has a robust cross-training plan that enables a flexible operation.

11.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.

12.Measures key performance indicators in area of responsibility. Ensures critical metrics are met including supply to patients (deliver results on time). Active participation in Tiers and Operational Excellence initiatives.

13.Is trained and develops expertise in laboratory electronic systems including LIMS, MODA, and DCA.

14.Supports the preparation of the annual budget, analyses capacity model and confirm headcount analysis as compared with projected hours. Escalates timely laboratory constraints to support business continuity. Ensures that laboratory expenses are according to the approved budget.
15.Leads site/inter-site meetings as required. Communicates with other sites and the Microbiology corporate team to look for feedback and standardization across sites.

16.Supports the Microbiology Laboratory in the absence of the Laboratory Sr Manager, upon request.

17.Ensures staff compliance BMS Human Resources policies and procedures and directly contributes on hiring, developing, coaching, corrective / disciplinary actions, recognition, terminations, and performance appraisal.

18.Develop mechanisms and a structure to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs. Act as a Change Agent for the organization.

19.Prepares CARs or generates/approves PO’s as required based on actual and future needs according to budget and provide required follow up.

20.Coordinates, evaluates and implements projects for area productivity. This includes the implementation of new laboratory equipment and methods.

21.Performs laboratory systems preventive maintenance checks (for example, LIMS, MODA, DCA) to ensure laboratory systems are well maintained.

22. Ensures laboratory equipment are operational and within calibration. Generates Work Orders for any laboratory or equipment fixes. Also ensures that all reagents and materials in the laboratory are within expiration dates.

23.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.).

24.Establishes a system for disposition of raw materials, API’s, finished products, packaging and labeling materials. As well as Environmental and Utilities samples.

25.Communicates on a daily basis with manufacturing to understand the needs and support needed and coordinates laboratory work accordingly.

26. 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.

27. Delivers microbiology results on time to ensure product disposition to the market.

28.Identifies opportunity areas in the processes to be more efficient and agile and pursue continuous improvement initiatives. Also supports and facilitates continuous improvement initiatives proposed by his/her direct reports.

29.Assures that stability studies performed at the site follow specific protocols and procedures and are tested on time.

30. 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 job’s functions.

31. Completes Annual Product Quality Review Report elements as established in products / systems schedule

SUPERVISION EXERCISED

Total number of employees supervised: 12

DECISION MAKING
  • The incumbent is responsible for the day-to-day decision making on technical matters within the microbiology laboratory.
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate curse of action.
  • Critical decisions will be made after consulting the Microbiology Laboratory Manager.
  • Makes decisions regarding personnel administration aspects such as hiring, performance evaluation, disciplinary actions, training and development and terminations among other administrative functions.
  • The incumbent makes difficult resources allocation recommendations & makes decisions consistent with priorities creating new ideas and processes, delivering results, driving for continuous innovation.
  • The incumbent is expected to work with minimal supervision, reporting on status & performance on a periodic basis to the Microbiology Laboratory Manager.
  • Notify immediate supervisor of any inconsistencies or violations to Company operation procedures and policies


CONTACTS
  • Daily contact with Sr manager, peers and personnel working directly under his/her responsibility.
  • Contact with personnel from other departments, such as: Manufacturing ,Engineering, Production, Finance and Planning.
  • Contact with QC/QA Departments in New Brunswick & Syracuse or other BMS plants inside and outside Puerto Rico.
  • Occasional contact outside the plant with vendors and customers.
  • Interaction with internal/external auditors, governmental agencies (FDA, EU, ANVISA, etc.) and other business related groups.


KNOWLEDGE / SKILL
  • Bachelor Degree in Microbiology, Biotechnology, Medical Technology, Biology 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 and Operational Excellence Tools
  • 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 and effective 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.


WORKING CONDITIONS

Describe exposure to any hazards / disagreeable conditions in the work environment:
  • May require working with hazardous chemicals and biohazardous materials such as microbial stock cultures (Biohazard Safety Level 1 and 2), culture media, acid and caustic solutions.
  • Use of microbiology and analytical laboratory related equipment such as autoclaves, glassware washers, microscopes, air monitoring devices, pH meter, balances, microbial identification equipment , glassware, UV, densitometer, conductivity meter, isolators
  • Use of required safety equipment such as, closed safety shoes, laboratory coat, coverall, safety glasses and/or half or full face mask.
  • Light physical exertion and moving up to 25 pounds.
  • Able to work and be in contact with biological drug products using the required protective equipment such as laboratory coat, coverall, gloves, half or full face mask and PAPR.
  • Able to frequently aseptically gown and de-gown using coverall, shoe cover and head covers as defined in the Manufacturing areas.
  • Able to climb stairs.
  • Minimum personal protective equipment (safety shoes, safety glasses, hard hat) required.
  • Able to move objects such as lifting, carrying, pushing and pulling. It involves body movement such as handling and fingering.


B. Travel required (describe nature and frequency):
  • Position may require travel both within and outside Puerto Rico. This accounts for approximately 7-10% of working month.

C. Overnight absences required (per typical month):
  • No significant absences from home per month not due to shift work.

BMS BL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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