Manager, QC Critical Reagents Molecular Team Lead
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.
The Manager is responsible for supporting and supervising Quality Control Critical Reagents Group with preparing molecular critical reagents and qualifying molecular and microbiology critical reagents. The incumbent is responsible for supporting and overseeing data review in accordance with applicable procedures and cGMP requirements. The incumbent oversees investigational testing and data review to support manufacturing of clinical and commercial CAR-T cell products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer. The Manager is responsible for continuously maintaining the GMP status of the QC Laboratory, applying and ensuring staff complies to EHS rules and safe work practices per applicable procedures.
Perform molecular and microbiology critical reagent qualification and investigational testing.
Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
Capable of handling complex issues and solving problems with only general guidance.
Prepare and present continuous improvement projects to management.
Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
Complete all work in a timely manner.
Communicate effectively within the team and across different teams to ensure timelines are met.
Perform review of testing data.
Review all data in accordance with applicable procedures and cGMP requirements.
Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
Complete all reviews in accordance with required release timelines.
Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Train new analysts to general job duties.
Complete necessary training to become a qualified trainer.
Perform training effectively.
Document training per procedural and cGMP requirements.
Support document revision, project, CAPA, and investigation/deviation tasks.
Perform assigned tasks within a CAPA, deviation, or project
Participate in complex projects and continuous improvement efforts.
Take a leadership role, as required, for projects.
Draft and review technical documents, such as SOPs and protocols/reports.
Communicate effectively with management regarding task completion, roadblocks, and needs.
Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
Supervises and develops direct reports including:
Management and scheduling of personnel within the department to meet testing qualification needs
Ensuring employees are properly trained and qualified to perform their assigned tasks.
Bachelor’s degree required, preferably in science. Advanced Degree preferred.
5-8 years of relevant work experience, preferable in a regulated environment.
Advanced hands-on experience with various molecular techniques and scientific knowledge in the characterization and transfer of pharmaceutical products.
Advanced hands-on experience with antibody titration technique.
Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
Advanced technical writing skills.
Advanced problem-solving ability/mentality, technically adept and logical.
Ability to represent the interests of the group on cross-functional teams.
Ability to set priorities of the group and manage timelines.
Ability to work with management locally and globally.
Advanced ability to communicate effectively with peers, department management and cross- functional peers.
Organizational and time management skills.
BMSCART, VETERAN, #LI-Onsite
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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