Engineer, Drug Product & Vector Labs - Bristol Myers Squibb
Summit, NJ
About the Job
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 .
Title: Engineer, Drug Product & Vector Labs
Location: Summit, NJ
BMS is looking for an Engineer to 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
#LI-Hybrid
BMSCART
VETERAN
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.
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/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1587296
Updated: 2024-11-13 03:12:21.881 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 .
Title: Engineer, Drug Product & Vector Labs
Location: Summit, NJ
BMS is looking for an Engineer to 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
#LI-Hybrid
BMSCART
VETERAN
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.
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/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1587296
Updated: 2024-11-13 03:12:21.881 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
