Manager, Senior Engineer I
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 CAR-T Global External Manufacturing Science and Technology Manager, Senior engineer I role is designed to support complex and technical aspects of CAR-T therapy manufacturing operations at external contract manufacturing organization (CMO) sites outside of the US. This role will have responsibilities in a wide variety of projects and tasks involving technical process support for Clinical/commercial products, lead process improvement initiatives, mentor junior engineers, implementation of new technologies at CMOs, product and process changes at CMO sites, as well as capacity expansion projects. The candidate will be responsible to review technical documentation, process monitoring, support changes, and enhancements to process documentation occurring at CMOs. This role will require collaboration with cross-functional team of members from QA, external manufacturing and GMSAT team members in different regions of the world.
These include, but are not limited to, the following
- Serve as product line SME(s), lead cross-functional team projects, and drive towards completion.
- Provide remote technical process support for routine manufacturing clinical and/or commercial cell therapy products at the CMO.
- Provide guidance and mentorship to junior engineers as required
- Review and approve manufacturing batch records, change controls, and deviations
- Work with technical and quality teams at CMO to evaluate and implement process improvements
- Author risk assessments and technical reports and revise process documents as needed to support process changes
- Perform and support data monitoring of manufacturing processes to understand process capability, resolve production issues and remote troubleshoot investigation-driven events
- Ensure the manufacturing process is in a state of control, through an understanding of CPV data.
- Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
- Assist with validation and startup activities that may include providing process training to support implementation of new technologies and specifications as well as process changes.
- Leverage and maintain strong relationships with external CMOs and their vendors.
- Support permanent inspection readiness and actively support regulatory inspections.
- Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.
- Share operational best practices and process learning with the rest of the manufacturing network.
- Foster innovative behaviors and strong inter-team relationships to achieve improvement goals.
- Complete regular assignments with minimum supervision.
Qualifications & Experience
Candidates must be comfortable and well-versed working in an online computer-based environment as vast majority of work is performed remotely across time zones. Onsite presence is required at New Jersey BMS office locations with up to 50% remote work from allowed with direct manager approval.
Desired candidates will have
- B.S. with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
- Experience in regulated GMP manufacturing environments
- Flexibility to work within regional manufacturing schedules
- Demonstrated ability to effectively work in cross functional teams, meet project deadlines, and prioritize multiple projects.
- Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
- Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization.
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
- Excellent problem-solving skills.
- Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
- Detail oriented with excellent verbal and written communication skills.
- Strong interpersonal and leadership skills to work with teams in different functions and organizations
- Excellent organization skills and ability to multi-task
- Ability to travel domestically and internationally, typically less than 10% of time.
- Experience in CAR-T therapies strongly preferred
- Operational excellence training/background is preferred.
- Ability to make decisions and work independently with a minimum supervision.
Desired candidates are technical professionals with 4-7 yrs experience in regulated medical, biotech, or pharmaceutical manufacturing environments. Requires a minimum a bachelor’s degree in engineering or life science from an accredited college or university. MSc or BSc in Biomedical Engineering, Chemical Engineering, Mechanical or Industrial Engineering or equivalent with minimum of 4+ years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
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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