Senior Scientist, Clinical Stage Process Development & Manufacturing Support, Gene Delivery & Editing Process Development

Bristol Myers Squibb

65d • $126,570 - $153,377

About The Position

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. 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.

Requirements

• PhD. with 2+ years of experience, M.S with 4+ years of experience, or B.S. with 7+ years of experience.
• Experience in a biotechnology process development or manufacturing environment for globally regulated products, such as cell & gene therapies, vaccines, or biologics.
• Demonstrated high level of technical expertise for one or more modalities supported by department (DNA via microbial processes, RNA via synthesis or in vitro transcription based processes, enzymes via microbial processes, ribonucleoproteins, viral vectors and cell lines).
• Experience supporting GMP oligonucleotide synthesis and/or GMP sterile fill/finish preferred.
• Experience with PD and/or early-stage clinical manufacturing with experience in managing process development and tech transfers and providing technical support for quality events.
• Experience writing and reviewing GMP documentation.
• Demonstrated ability to develop and apply sophisticated tools for analysis of process and manufacturing data (data engineering).
• Experience authoring regulatory documents and submissions.
• Experience with cGMP and ICH guidelines.
• Proven ability to work in a fast-paced, multi-product, matrixed environment spanning groups at different geographical locations.
• Ability to communicate clearly and concisely through oral presentation and technical writing, including development reports and regulatory filings.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects.
• Desire and drive to increase access of cell and gene therapy products and passion for their impact on the lives of patients with serious diseases.
• Open to working in the wet-lab to support generation of data for support of tech-transfer/facility fit, change controls, investigations.

Responsibilities

• Lead process and technology transfers, change management, and technical process support for successful clinical stage manufacturing of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors and cell lines.
• Represents department on cross-functional CMC teams with a high degree of independence.
• Negotiates project timelines and deliverables.
• Accountable for communicating changes to department and project leadership.
• Act as overall CMC lead for GDE materials and/or lead cross-functional technical teams when needed.
• Provides high level technical guidance for clinical manufacturing site selection and process decisions.
• Applies a risk-based approach to strategy decisions; identifies and can communicate risks to management.
• Conduct due diligence to assess onboarding of new gene-delivery vendors.
• Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, and provide technical support for quality events for manufacturing of gene-delivery raw materials.
• Visit internal and external manufacturing sites as needed to support tech transfer activities, ensure manufacturing success as person in plant, and assist regulatory inspections.
• Develop, implement, and optimize early-stage tech transfer plan to streamline transition from PD to clinical manufacturing teams.
• Identify technical gaps in the form of risk assessments and work with PD colleagues to de-risk tech transfer, scale up/scale down and improve clinical vector processes throughout the clinical development period.
• Author manufacturing and process development sections of regulatory filings as well as technical documents suitable for presentation to regulatory authorities.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees