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Senior Engineer, Viral Vector Process Development Pilot Lab

1 month ago

Olympia, United States Bristol-Myers Squibb Full time

**Senior Engineer, Viral Vector Process Development Pilot Lab** CAROUSEL_PARAGRAPH * Seattle, Washington * Drug Dev and Preclinical Studies * R1545225 * Full Time * 12/07/2021 **

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** Job Description** 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. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMSs continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. We are seeking an enthusiastic, self-driven individual to join the Viral Vector & Gene Editing Process Development team (VVPD). Our team develops process and technology underpinning critical raw materials used in the manufacturing of engineered T cells, including viral vector. The primary focus of this position will be to drive process development of scalable, manufacturing-friendly viral vector processes, and provide non-GMP grade viral vector for pre-IND studies. This scientist will lead a team and dedicated facility responsible for internal process tech-transfer, scale-up and production of AAV and lentiviral vectors, and will contribute to the strategic development of viral vector process platforms. The ideal candidate will have experience operating suspension-based cell culture processes (upstream and downstream) in a manufacturing environment. *Responsibilities:* * Build and manage a team of scientist/engineers responsible for pilot-scale (10-50L) process development and manufacturing * Lead facility startup activities including: equipment installation, operator training, and initial operation/commissioning runs * Ensure appropriate framework documentation governing facility, equipment, process, and safety is authored and approved * Guide transfer of external viral vector processes into the pilot lab * Lead execution of pilot-scale material generation runs * Implement and maintain a facility scheduling capability * Collaborate with lab manager to ensure necessary supply of single-use consumables * Represent viral vector and process development at CMC and cross-functional team meetings * Support tech transfers out of VVPD and on-going activities with external collaborators and service providers (CMOs, CROs) * Support the creation of next-generation technologies and platforms for viral vector manufacturing, paying particular attention to scalability and robustness Education: * B.S. in Chemical Engineering, Bioengineering, or similar discipline Qualifications: * 6-10 years experience in a biotechnology process development or manufacturing environment for globally-regulated products, such as vaccines, biologics, or cell & gene therapies * Hands-on operation of single-use bioreactors especially Xcellerex XDR and WAVE platforms * Hands-on operation of downstream bioprocessing equipment especially AKTA Pilot and NFF/TFF skids * Authoring and reviewing manufacturing facility and process documentation especially: Standard Operating Procedures (SOPs), Batch Records (BRs), process transfer documents, safety plans, and campaign summaries * Familiarity with Quality Management Systems (QMS) used to house GxP documentation (e.g. Veeva Vault QualityDocs, ETQ, Qualio) * Effective communication including presentations to convey scientific concepts to research scientists, management teams, and external academic and industrial organizations * Previous work on process transfer including interfacing with contract manufacturing and development organizations * Prior success in managing small, high performing teams If you want to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. BMSCART 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 adastaffingsupport@bms.com . Visitto 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.

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