Bristol Myers Squibb
Scientist, Process Technology Operations
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Scientist, Process Technology Operations
Join to apply for the
Scientist, Process Technology Operations
role at
Bristol Myers Squibb .
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 work 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.
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.
Role & Responsibilities
Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, review and approval of change controls and preparation of regulatory filings.
Performs root cause investigations and develops CAPAs as needed for process deviations.
Develops process performance data trending for continuous process verification and process improvement.
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
Willingness to provide on‑call support for 24x7 manufacturing facilities as needed.
Demonstrate a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures. Incorporate into all assigned projects.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.
Manages projects to coordinate activities and provide updates to management on a routine basis.
Evaluates process performance by comparing manufacturing data to historical data from other sites, reports variances to management with recommendations for process enhancement.
Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
Participates in the preparation of regulatory filing documents and inspection readiness.
Experience & Qualifications
PhD and 0‑2 years of relevant experience or Master's degree and 2‑4 years of relevant experience or Bachelor's degree and 5‑7 years of relevant experience.
Knowledge of process engineering and science generally attained through studies resulting in a B.S., in engineering (like Biochemistry, Chemical or Biotechnology), a related discipline, or its equivalent. Graduate education through M.S. or Ph.D. is highly desired.
Mastery of SOPs, cGMPs and the know‑how to work and manage within a regulatory environment.
Demonstrated competency in successful execution of process technical transfer.
Experience in the design, modification and optimization of biologics production processes.
Experience in designing and executing process and equipment validation plans.
Strong experience in investigating process deviations and developing issue resolving CAPAs.
Proven success working with and leading cross‑functional project teams.
Demonstrated competency in project management that includes leading cross‑functional teams and effectively balancing project assignments with other duties.
Broad knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi‑disciplinary teams.
Compensation Overview Devens – MA – US: $114,290 – $138,494
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefits
Health Coverage: Medical, pharmacy, dental and vision care.
Well‑being Support: Programs such as BMS Well‑Being Account, BMS Living Life Better and Employee Assistance Programs (EAP).
Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.
Work‑life benefits include
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays and 3 optional holidays.
Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part‑time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The summer hours program is for United States (U.S.) office‑based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote‑by‑design or lab‑based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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 a supportive culture, promoting global participation 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.
Supporting People With Disabilities 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 https://careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
California Residents 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/.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
Job ID: R1597690 – Scientist, Process Technology Operations
#J-18808-Ljbffr
Scientist, Process Technology Operations
role at
Bristol Myers Squibb .
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 work 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.
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.
Role & Responsibilities
Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, review and approval of change controls and preparation of regulatory filings.
Performs root cause investigations and develops CAPAs as needed for process deviations.
Develops process performance data trending for continuous process verification and process improvement.
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
Willingness to provide on‑call support for 24x7 manufacturing facilities as needed.
Demonstrate a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures. Incorporate into all assigned projects.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.
Manages projects to coordinate activities and provide updates to management on a routine basis.
Evaluates process performance by comparing manufacturing data to historical data from other sites, reports variances to management with recommendations for process enhancement.
Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
Participates in the preparation of regulatory filing documents and inspection readiness.
Experience & Qualifications
PhD and 0‑2 years of relevant experience or Master's degree and 2‑4 years of relevant experience or Bachelor's degree and 5‑7 years of relevant experience.
Knowledge of process engineering and science generally attained through studies resulting in a B.S., in engineering (like Biochemistry, Chemical or Biotechnology), a related discipline, or its equivalent. Graduate education through M.S. or Ph.D. is highly desired.
Mastery of SOPs, cGMPs and the know‑how to work and manage within a regulatory environment.
Demonstrated competency in successful execution of process technical transfer.
Experience in the design, modification and optimization of biologics production processes.
Experience in designing and executing process and equipment validation plans.
Strong experience in investigating process deviations and developing issue resolving CAPAs.
Proven success working with and leading cross‑functional project teams.
Demonstrated competency in project management that includes leading cross‑functional teams and effectively balancing project assignments with other duties.
Broad knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi‑disciplinary teams.
Compensation Overview Devens – MA – US: $114,290 – $138,494
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefits
Health Coverage: Medical, pharmacy, dental and vision care.
Well‑being Support: Programs such as BMS Well‑Being Account, BMS Living Life Better and Employee Assistance Programs (EAP).
Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.
Work‑life benefits include
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays and 3 optional holidays.
Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part‑time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The summer hours program is for United States (U.S.) office‑based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote‑by‑design or lab‑based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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 a supportive culture, promoting global participation 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.
Supporting People With Disabilities 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 https://careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
California Residents 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/.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
Job ID: R1597690 – Scientist, Process Technology Operations
#J-18808-Ljbffr