Senior Associate Scientist, Gene Delivery & Editing Process Development

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Title: Senior Associate Scientist, Gene Delivery & Editing Process Development
Location: Seattle, WA

We are seeking an enthusiastic, self-drivenSenior Associate Scientistto join the Gene Delivery & Editing Process Development team. Our team develops the end-to-end processes and technologies to deliver the critical raw materials used in the manufacturing of engineered T cells, including viral vectors. This team member will play a key role in the tech transfer and support of clinical manufacturing (up to process performance qualification (PPQ)) of gene-delivery raw materialssuch as: DNA, RNA, Enzymes, RNPs, viral vectors, and cell lines.The ideal candidate will have experience with process development and/or early-stage clinical manufacturing including proficiency in supporting tech transfers, deviations, change controls, and OOS investigations. Hands on experience operating production processes in a manufacturing environment is desirable.

Key Responsibilities:
Support 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.
Focus on AAV and DSP activities.
Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, managing process deviations and out of specification investigations through approved quality systems for manufacturing of gene-delivery raw materials
Visit internal and external manufacturing sites as needed to support OOS investigations, tech transfer activities, and regulatory inspections
Support the development and implementation of 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
Provide technical documentation supporting manufacturing and process development sections of regulatory filings
Up to 25% travel

Qualifications & Experience:
M.S. with 2+ years of experience or B.S. with 3+ years of experience in process development or commercial manufacturing
Experience in a biotechnology process development or manufacturing environment for globally regulated products, such as cell & gene therapies, vaccines, or biologics
Experience with PD and/or early-stage clinical manufacturing with experience in process development, tech transfers, Deviations and OOS investigations.
Experience writing and reviewing GMP documentation
Experience using statistical software (ex. JMP) for analysis of process and manufacturing data
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

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.

The starting compensation for this job is a range from$82,000 - $102,000, plus incentive cash andstock 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 demonstratedexperience. Eligibilityfor specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS
Career Site.

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). Financialwell-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance,supplemental healthinsurance, business travel protection and survivor support. Work-life programs include paid national holidays and optionalholidays, GlobalShutdown 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/infertilitybenefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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