Senior Associate Scientist/Scientist, Gene Delivery Process & Analytical Development

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Cell Therapy is one of the most groundbreaking new forms of cancer treatment being studied today. With therapies only in their infancy and BMS’s 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 Gene Delivery Process & Analytical Development (GDPAD) team. Our team develops the end-to-end processes and technologies used to deliver the critical raw materials for the manufacturing of engineered T cells. This team member will play a key role in product tech transfer and lifecycle management for clinical and pre-clinical portfolios for gene-delivery raw materials such as viral vectors, DNA, cell lines, RNA, Enzymes, and RNPs.

This team member will monitor clinical manufacturing up to process performance qualification (PPQ) identifying and managing implementation of process improvements, process deviations, change controls, and out of specification investigations through approved quality systems. Additionally, this team member will be involved with authoring of technical documents suitable for presentation to regulatory authorities. This team member will work closely with process development colleagues to identify technical gaps in the form of risk assessments, de-risk tech transfer, scale up/scale down, and improve processes throughout the clinical development period. As part of managing the manufacturing of gene-delivery raw material, this team member will be responsible for generating change controls and managing deviations as they occur.

• Lead process and technology transfers, change management, and technical process support for viral vectors, DNA, cell lines, RNA, Enzymes, and RNP products through PPQ
• Lead collaborations with process development teams to perform risk assessments, scale up/down, and identify areas of process improvement throughout clinical development
• Act as a technical Subject Matter Expert (SME) within the GDPAD group and on various project teams
• Perform data monitoring of manufacturing processes to understand process capability, and trouble-shoot investigation-driven events
• Author and/or review manufacturing documentation as needed
• Collect, analyze, and present manufacturing data to internal and external stakeholders
• Support the authoring of regulatory filings
• Oversee externalized technology collaborations to improve process platforms
• Provide technical onsite oversight during technology transfer and manufacturing of gene-delivery raw materials as needed

• PhD. (entry level), M.S. with 3 years of experience or B.S. with 5 years of experience in process development or commercial manufacturing
• Experience with process development and/or early-stage clinical manufacturing with experience in managing process development, tech transfers, deviations, change controls, and OOS investigations
• Demonstrated ability to perform/document complex manufacturing processes
• Experience writing, and reviewing GMP documentation
• Experience providing technical support in either a clinical/commercial GMP environment
• Experience with cGMP, ICH guidelines, process validation, and control strategy development
• Exceptional problem-solving and risk-based decision-making skills
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects
• Ability to communicate clearly and concisely through oral presentation and technical writing, including development reports and regulatory filings

The starting compensation for this job is a range from $75,000-$115,000 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our website https://careers.bms.com/working-with-us

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

If you have a passion for taking on new challenges in a fast-paced and dynamic environment, are dedicated to excellence and want to make a difference, we're excited to hear from you! The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge of viral vectors, in gene editing, analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. 

BMSCART

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Salary : $75,000 - $115,000