Manager, QC, Bioanalytics (R1555719-en-us)
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.
POSITION SUMMARY: (briefly state position overview)
The Manager, QC, Bioanalytics is responsible for staff in lab area performing testing, analysis, and results reporting of drug substance and drug products. The QC Bioanalytics Manager is accountable for ensuring a safe, quality driven, efficient, and robust culture while continuously challenging inefficiency at every opportunity.
Duties/Responsibilities: (describe the most critical responsibilities/accountabilities of this position)
Oversee all operations functions within the Bioanalytics lab 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.
- Responsible for day-to-day operations of the laboratory, including on-time testing, analysis of data and trends, investigations, staff training and equipment maintenance and calibration.
- Develop and oversee staff schedules to meet workflow demands of the 24/7 manufacture of drug substance and on time release of final bulk drug substance.
- Responsible for ensuring all activities are carried out to the highest standards of EHS compliance
- Provide technical and operational expertise for the training and development of staff, assistance in troubleshooting, conducting investigations for out of specification results.
- Responsible for the development of high-quality team members with diverse backgrounds and talent capable of delivering against established goals and objectives
- Responsible for adherence to SOPs, Directives, cGMPs, FDA, OSHA, ICH, and other regulatory agency requirements
- 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
- Establish and communicate high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and improve laboratory efficiency
Specific Knowledge, Skills, Abilities, etc: (describe the most critical competencies which are required to perform the job)
- Demonstrated leadership and team building skills gained through previous supervisory roles or project management.
- Demonstrated interpersonal, communication, motivational, and problem-solving skills.
- Strong working knowledge of cGMP requirements and regulations FDA, EMA.
- Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
- Strong working knowledge and in depth understanding of analytical techniques preferred such as cell based Bioassays, ELISA, qPCR etc.
- Knowledge of applicable business systems (e.g., SAP, LIMS, LES)
Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
- 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 6 years’ experience in a cGMP environment with previous leadership experience preferred
- Experience supporting regulatory agency inspections preferred
Physical Demands: (see items to consider on last page)
This position is a primarily an office-based position, however, requires routine entry into laboratories to provide oversight as needed.
Work Environment: (see items to consider on last page)
This position is an office-based role with routine 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).
Supervisory Responsibilities: (only include if supervisory responsibilities are required)
- Will supervise a direct staff of 4-10 employees
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.
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