Engineer, Drug Product & Vector Labs

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Title: Engineer, Drug Product & Vector Labs
Location: Summit, NJ

BMS is looking for anEngineerto join the Vector Labs Cell Therapy Technical Operations department. The position will be responsible for the routine MSAT lab activities: equipment maintenance, experimental design and execution, and support PPQ strategies and commercial manufacturing. The Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations in the lab. The role will be cross-functional and will interact with other groups This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Engineer will play a key role in product lifecycle management, including strategic development, characterization, commercialization, and evolution of cell therapy products.

Key Responsibilities:
The initial focus area for this position is to support the onboarding of the new Vector/Drug Product/Analytical CTTO lab.
Create and revise technical documentation (e.g. changes controls, SOPs, and batch records)
Support the implementation of new technologies and procedures into the lab
Support the design and execution of studies to support commercial manufacturing deviation investigations.
Support the design and execution of process characterization studies.
Collaborate with commercial vector and drug product teams to identify opportunities for process improvements
Provide data collection, interpretation, and analysis on manufacturing and manufacturing support processes. Determine areas of opportunity, shifts and trends, and states of control
Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality Assurance and External Manufacturing.
Performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams.

Qualifications & Experience:
PhD in Chemical Engineering, Biology, or equivalent with 1+ years of relevant experience in process development or commercial manufacturing
Knowledge of lentiviral vector and drug product manufacturing is required

Experience in a viral vector commercial support lab is required
Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.

Experience in development and/or characterization of cell therapy manufacturing processes
Experience with cGMP, ICH guidelines, PPQ (process validation), and working with a Quality organization
Experience working in a self-driven, performance/results oriented, fast paced matrix environment
Experience or knowledge of statistical analysis using statistical software package
Able to creatively manage time and elevate relevant issues to project lead and line management
Strong scientific and technical writing
Detail oriented with excellent verbal and written communication skills
Ability to travel domestically and internationally
Yellow Belt Certification and Lean Six Sigma project experience is required
Experience in a drug product commercial support lab is preferred
Highly prefer candidate with Abecma Vector experience and process knowledge

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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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