Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Bristol-Meyers Squibb, Co.

Manager - QC Lab Operations (R1557229-en-us)

Pharmaceuticals

All

Yearly

No

Summit, New Jersey, 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.

Summary:

The Manager I is responsible for managing a QC Laboratory team and also working as a subject matter expert for qualification, testing and release of consumables and raw materials used in CAR-T manufacturing during clinical and commercial phases. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, this position will be responsible for the preparation of data, data integrity auditing and providing contributions to regulatory submission documents.

Duties & Responsibilities:

Manages activities related to the Network QC department including:

  • GMP release of incoming consumables, raw materials, and critical reagents. Release management support may be required at multiple local sites

  • Documentation of GMP release activities.

  • Handle/Manage Quality Events such as Deviations, Investigations, Change Control, CAPA, Risk/Gap Analysis

  • Method development, Method Validation and Method Transfer for incoming consumables and raw materials.

  • Qualification of raw materials for clinical and commercial manufacturing.

  • Manage/Implement Lab Compliance Activities such as Lab Audits/Inspections

  • Work as SME for Health Authority/Internal Audits

Manages and develops direct reports including:

  • Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.

  • Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.

Perform testing of in-coming raw materials and consumables.

  • Utilize advanced scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.

  • Capable of handling complex issues and solving problems with minimum guidance.

  • Comprehensive understanding of regulatory guidelines and can independently develop, write, and execute SOPs, methods, protocols, reports and other related documents.

  • Manage testing performed at contract testing laboratories.

Drive and Manage projects within the group

  • Accepts responsibility for group projects; designs and executes experiments, analyzes results, and writes technical summary reports.

  • Capable of handling complex issues and solving problems with minimum guidance.

  • Prepare and present continuous improvement projects to management.

  • Utilize advanced scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.

  • Comprehensive understanding of guidelines and can independently develop, write and execute SOPs, method, protocols, reports, and other related documents.

  • Assist management with investigations and deviations.

Carry out management authority for review and approval activities

  • Serve as author or technical reviewer of appropriate departmental procedures.

  • Review Laboratory Data/documentation as required by laboratory procedures.

  • Perform approvals for relevant laboratory activities.

Provide Guidance and Leadership

  • Perform on-the-job training (OJT) for laboratory employees.

  • Assist management with the development, implementation, and deployment of training.

  • Coach analyst on troubleshooting analytical methods and scientific equipment.

  • Teach junior scientists on theory and application of analytical methods.

  • Lead and develops best practices.

Performs other tasks as assigned.

Education & Experience:

  • Bachelor’s Degree required in Science, Preferably in Pharmaceutical Science/Chemistry

  • Advanced Degree (MS, MBA) preferred

  • 8 years of relevant work experience, preferable in a regulated environment.

  • An equivalent combination of education and experience may substitute.

  • At least 1-2 years of People Management (Team Leadership) Experience

Required Competencies:

  • Advanced experience and knowledge of Compendia methods and requirements such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP)

  • Deep knowledge of AQL/ANSI Standards

  • Advanced hands-on experience with various analytical techniques and scientific knowledge in, but not limited to, HPLC/UPLC, GC, FTIR, Osmolarity, Endotoxin testing, Particle Size Distribution, and pH

  • Advanced ability to understand, follow, interpret, and apply Global Regulatory, cGMP requirements and ISO requirements for devices accurately and completely.

  • Advanced ability to interact with regulatory auditors as Subject Matter Expert (SME).

  • 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 knowledge of data trending and tracking.

  • Advanced ability to communicate effectively with peers, department management and cross- functional peers.

  • Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.

  • Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.

  • Ability to interpret and author general, technical, and complex business documents.

  • Advanced knowledge and implementation of data integrity principles.

  • Ability to represent the department in regulatory inspections.

  • Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.

  • Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.

  • Advanced teamwork and facilitation skills.

  • Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.

Working Conditions:

  • The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.

  • The incumbent must analyze numerical values on a daily basis.

  • The incumbent will be working a laboratory setting up to six (6) hours per day.

  • The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.

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.