Senior Scientist, Gene Delivery and Editing Process Development Full-time

Senior Scientist

The Senior Scientist will join the Gene Delivery and Editing Process Development (GDEPD) organization supporting process development, production, and characterization of viral vectors, which are critical to generating BMS's groundbreaking cell therapies. The candidate will help drive next-generation viral vector platform development and support the advancement of clinical programs.

Responsibilities:

• Design, execute, and troubleshoot downstream development experiments supporting next-generation AAV production
• Identify, onboard, and develop novel downstream technologies in collaboration with internal and external partners
• Lead external manufacture of AAV asset(s) at partner CDMO, including FIH tech transfer, regulatory authoring, and life-cycle support through pivotal process development and manufacturing
• Optimize downstream unit operations and support clinical and commercial scale-up
• Provide experimental design and executional support to team members, mentorship of junior staff
• Craft and articulate experimental, project, and program timelines
• Leverage knowledge of business needs to strategically communicate progress, timelines, and impacts to senior leaders in the organization
• Support cross-functional development efforts e.g. upstream process development, high-throughput process development
• Support research-to-development transition endeavors, including early-stage/pipeline molecular assessment activities
• Support vector attribute science identification initiatives
• Actively participate and support lab maintenance, buildout, and continuous improvement initiatives
• Work independently and within teams to design, execute, and analyze experiments
• Maintain accurate and detailed laboratory notebook and documentation
• Summarize and present data in group meetings and contribute to group discussions and team strategy
• Identify, drive, and champion new initiatives for knowledge management and data warehousing
• Represent GDEPD within cross-functional teams
• Act as vector PD lead on CMC teams
• Support tech transfer and on-going activities with external collaborators and service providers (CDMOs, CROs) including serving as primary point-of-contact
• Author technical reports and study memos
• Publish in peer reviewed journals, present at conferences, interface with broader industry

Basic Qualifications:

• Degree in biological or chemical engineering, biochemistry, or bio-related field with 5+ years of relevant industry experience; title/compensation will ultimately be commensurate with education, experience, and skillset
• End-to-End downstream subject matter expert
• Subject matter expert in process development
• Expertise in viral vector process development
• Expertise in tech transfer and GMP manufacturing
• Knowledge of late-stage PD activities (e.g. PC, PPQ)
• Working knowledge of scale up parameters for downstream operations
• Proven ability to design experiments with DoE approaches, execute DoE designs and interpret the results
• Independently motivated with ability to work in cross-functional teams
• Able to manage and mentor as many as 3 direct reports
• Experience interfacing with contract manufacturing and development organizations
• Ability to communicate clearly and concisely through oral presentation and technical writing
• Ability to leverage literature, internal and external resources to solve problems
• Desire to identify and advance the cutting edge
• Possess a growth mindset and the ability to thrive in a fast-paced, highly collaborative environment
• Experience giving presentations at industry conferences
• Experience with processes intensification and process analytical technologies (PAT)
• Experience establishing and industry (e.g. vendor) and/or academic collaborations

Preferred Qualifications:

• Experience in the development of viral vectors (e.g. adeno-, retro-, lenti-), including successful transfer for GMP manufacturing
• Expertise in late-stage biologics PD
• Working knowledge of regulatory affairs as they relate to biologics and ATMPs
• Working knowledge of upstream process development
• Track record of intellectual property generation
• Record of external publication
• Experience with process modeling, mechanistic modeling, and statistical interpretation of results
• Experience with data pipelines and knowledge management
• Experience with single-use technologies
• Experience with late-stage development
• Graduate degree in biotech / bio or chem engineering field (i.e. MS or PhD)

Additional Job Requirements:

Position Handles Hazardous Materials

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