Process Engineer II - Manufacturing Sciences and Tech Operations
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 Process Engineer II 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 implementation of new technologies at CMO sites, process improvement initiatives, product and process changes at CMO sites, as well as capacity expansion projects. It is also designed to support routine manufacturing operations including supporting complex manufacturing deviations, change impact evaluations, technical documentation review and approvals, process monitoring, and continuous process verification. This role will require close collaboration with GMSAT team members in Seattle and New Jersey as well as regional virtual plant team members in different regions of the world.
These include, but are not limited to, the following
- Support process and technology transfers, change management, and provide technical process support for routine clinical and commercial cell therapy products at the CMO.
- Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations when needed.
- Assist with creation and revision of technical documentation (e.g. changes controls, SOPs, and batch records)
- 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.
- Assist with deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenging deviations and drive them towards closure.
- Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
- Support production related investigations, ensuring compliance with internal standards and regulatory requirements
- Perform monitoring of manufacturing processes to understand process capability.
- Leverage and maintain strong relationships with external partners
- Support new product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
- Support permanent inspection readiness and actively support regulatory inspections
- Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
- Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product
- Deliver communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
- Foster innovative behaviors and strong inter-team relationships to achieve improvement goals.
- Complete regular assignments with minimum supervision.
- Participate in internal learning and sharing events. Participate in external learning and training events related to Cell and Gene Therapy industry and related manufacturing topics.
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 either Seattle or New Jersey BMS office locations with up to 50% remote work from allowed with direct manager approval.
Desired candidates will have
- B.S. with 2-4 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
- Strong interpersonal and leadership skills to work with teams in different functions and organizations
- Experience or knowledge of statistical analysis using statistical software package. Examples include jmp, Minitab, R
- Technical writing skills with ability to author peer reviewed protocols and reports, production batch records, standard operating procedures
- Ability to complete projects and tasks in partially remote setting without face-to-face supervision
- Ability to function effectively in a structured and regulated work environment by navigating and complying with Standard Operating procedures and quality management processes.
- Demonstrated proficiency with effective and proactive written and verbal communication appropriate for technical and regulated work environment
- Excellent organization skills and ability to multi-task
- Ability to travel domestically and internationally, typically less than 5% of time.
- Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies preferred
- Experience with CAR-T therapies strongly preferred
Desired candidates are technical professionals with 2 - 4 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. Preferred specialties are: Mechanical, Chemical, Industrial, or Biomedical engineering.
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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