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Bristol-Meyers Squibb, Co.

Senior Manager, QC, Release (R1555915-en-us)

Pharmaceuticals

All

Yearly

No

Syracuse, New York, United States

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.

Bristol-Myers Squibb in Syracuse, NY is searching for a Quality Control (QC) Senior Manager is responsible for laboratory operations within a functional area of expertise that support the onsite commercial biologics manufacturing facility, as well as applicable network and third-party manufacturing facilities.

Functional areas of expertise include Bioseparations , Bioanalytics, and chemistry methodologies for the testing of raw material, in-process, release and stability for drug substance and drug product samples. The Senior Manager is accountable for ensuring a safe, quality driven, efficient, and robust culture while continuously challenging inefficiency at every opportunity.

Duties/Responsibilities:

Oversee all operations functions within area of expertise to direct the development, implementation, and refinement of standards, methods, procedures, laboratory facilities for execution of testing and reporting in accordance with cGMP and SOPs.

  • Oversee the daily operation of a biologics QC lab testing and reporting of raw material samples, in process samples, and final bulk product samples to support the manufacturing of bulk drug substance.
  • Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.
  • Lead a health and safety culture to maintain a safe working environment in the laboratory.
  • Provide technical and operational expertise for the training and development of staff, assistance in troubleshooting, conducting investigations.
  • Accountable for adherence to schedules for sample analysis to support the 24/7 manufacture of drug substance and on time release of final bulk drug substance.
  • Create an environment of continuous learning, improvement, and innovation.
  • Accountable for adherence to SOPs, Directives, cGMPs, FDA, OSHA, ICH, and other regulatory agency requirements.
  • Ensures all personnel have adequate training, education, and experience to perform their GMP related job function effectively.
  • Serve as Subject Matter Expert and participate in the network and site team supporting investigations, method updates, reagent qualifications, tech transfer, regulatory inspections, and audits.
  • Provide strategic leadership across the teams through high performance standards, clear accountability, and continuous improvement strategies to reduce operational variances and improve laboratory efficiency.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

  • Demonstrated leadership, interpersonal, communication, motivational, and problem-solving skills.
  • Knowledge of biopharmaceutical manufacturing and analytical testing is highly desirable.
  • Extensive knowledge of regulatory requirements (e.g., US, EMA, USP) and industry best practices.
  • Knowledge of applicable business systems including (e.g ., SAP, LIMS, LES, Maximo)

Education/Experience/ Licenses/Certifications:

  • Knowledge of science generally attained through studies resulting in a B.S. in physical or life sciences (e.g. chemistry, biochemistry, molecular biology, or related discipline) or its equivalent.
  • Minimum of 8 years’ experience in a cGMP environment with previous management of personnel preferred
  • Experience building and growing an organization into a high-performance team and influencing in a matrix environment
  • Proven experience in FDA (or other regulatory authority) inspection preparation and management

Physical Demands:

Primarily an office based role in which one must be aware of the presence of general office based ergonomics

Work Environment:

This position is an office-based role with occasional exposure to laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including; pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, hazardous chemical reagents, and biohazardous materials (e.g. live cell cultures).

Travel:

This position requires up to 5 % of travel.

Supervisory Responsibilities:

  • Will supervise a direct staff of 3-6 employees with multi-level organization.

BMSBL, VETERAN

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 . Visit[Register to View] target="_blank"> [Register to View] 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.