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Scientist, Process Technology Operations - Devens, MA
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Scientist, Process Technology Operations - Devens, MA
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS – Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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. 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.
Join Bristol Myers Squibb’s biologics manufacturing support team as a Scientist within Manufacturing Science and Technology, where you’ll play a pivotal role in resolving process deviations, leading root cause investigations, and developing corrective actions to maintain the highest standards of GMP compliance. As a key contributor, you’ll drive process performance improvements through data analysis and trending, author technical protocols and SOPs, and collaborate across teams to advance biopharmaceutical manufacturing. If you thrive in a dynamic, data-driven environment and are committed to excellence in patient-focused therapies, we invite you to shape the future with BMS.
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.
Minimum Education Required Bachelors
Additional Qualifications/Responsibilities
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 knowhow 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 include 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.
Location Devens, Massachusetts, USA
Employment Type Full-time
Seniority Level Mid‑Senior level
Job Function Research, Analyst, and Information Technology
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS – Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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. 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.
Join Bristol Myers Squibb’s biologics manufacturing support team as a Scientist within Manufacturing Science and Technology, where you’ll play a pivotal role in resolving process deviations, leading root cause investigations, and developing corrective actions to maintain the highest standards of GMP compliance. As a key contributor, you’ll drive process performance improvements through data analysis and trending, author technical protocols and SOPs, and collaborate across teams to advance biopharmaceutical manufacturing. If you thrive in a dynamic, data-driven environment and are committed to excellence in patient-focused therapies, we invite you to shape the future with BMS.
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.
Minimum Education Required Bachelors
Additional Qualifications/Responsibilities
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 knowhow 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 include 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.
Location Devens, Massachusetts, USA
Employment Type Full-time
Seniority Level Mid‑Senior level
Job Function Research, Analyst, and Information Technology
#J-18808-Ljbffr