Manager, Downstream Clinical Manufactuing - Bristol Myers Squibb
Devens, MA
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 .
Manager, Bioprocess Manufacturing Operations
Excited to grow your career?
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Our growing campus is located 45 miles northwest of Boston in Devens, MA. The site totals 700,000 square feet on 89 acres and currently supports process development, clinical manufacturing and commercial manufacturing for biologics medicines and construction is underway for a new state of the art Cell Therapy facility. This is an exciting time to join BMS in Devens and be part of our expanding team!
Position Summary
The Manager position is in the Single Use Facility in the Devens, MA campus on the second shift (Monday - Friday 2PM to 10PM). The Manager leads and drives the execution of commercial manufacturing processes according to established procedures and production batch records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP's). The Manager is responsible for management of group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Manager is required to guide the personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.
Key Responsibilities
+ L ead the operation of all area-specific production equipment (i.e., CIP systems, bioreactors, chromatography systems, media/buffer preparation equipment etc.), process automation systems (i.e., Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e., SAP. Trackwise, Maximo etc.)
+ Ensure team adherence to Good Manufacturing Practices (GMPs) and standard operating procedures (SOPs)
+ Ensure daily work coordination and distribution as demanded through Bio G schedule to effectively manage production
+ Manage daily communication to shift personnel, support functional team meetings, ensure shift notes are thorough and accurate, and provide shift handover support and critical update summaries to other Shift Supervisors
+ Ensure oversight on critical operations through systematic walk down and checks prior to execution
+ Develop and manage operational schedule in conjunction with scheduling and planning team, recognize cross-functional impact, and capture and communicate any variance to cross-functional groups in real time
+ Act as an area/system owner and point of contact for all work to be carried out in the area over assigned shift
+ Build partnership with assigned Technical Lead to ensure daily data review and trends are accomplished
+ Take active role in selecting and developing team; this includes leveraging relationships internal and external to the SUF manufacturing team to build the best team possible, developing less experienced Technical Leads, and providing general mentorship and training to staff
+ Manage staff performance and prepare performance objectives for mid-year and end-of-year performance connection reviews
+ Drive continuous improvements through staff engagement
Qualifications & Experience
+ Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired
+ 6+ years of direct biologic manufacturing experience, with 2+ years of previous supervisory experience demonstrating proficiency in selection of team and management of personnel highly desired
+ Extensive knowledge of SOPs and cGMPs and their application within a regulatory environment
+ Knowledge of pharmaceutical and biopharmaceutical manufacturing process generally obtained through participation in pharmaceutical technology, technology transfer, process development, and manufacturing support
+ Demonstrated aptitude for engineering principles and manufacturing automation systems
+ Ability to effectively work in a cross-functional, fast-paced, complex, and dynamic environment
+ Effective communication and technical writing skills
#LI-Onsite
#VETERAN
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Locations
Devens - MA - US
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: R1587017
Updated: 2024-11-22 06:14:30.733 UTC
Location: Devens-MA
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 .
Manager, Bioprocess Manufacturing Operations
Excited to grow your career?
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Our growing campus is located 45 miles northwest of Boston in Devens, MA. The site totals 700,000 square feet on 89 acres and currently supports process development, clinical manufacturing and commercial manufacturing for biologics medicines and construction is underway for a new state of the art Cell Therapy facility. This is an exciting time to join BMS in Devens and be part of our expanding team!
Position Summary
The Manager position is in the Single Use Facility in the Devens, MA campus on the second shift (Monday - Friday 2PM to 10PM). The Manager leads and drives the execution of commercial manufacturing processes according to established procedures and production batch records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP's). The Manager is responsible for management of group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Manager is required to guide the personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.
Key Responsibilities
+ L ead the operation of all area-specific production equipment (i.e., CIP systems, bioreactors, chromatography systems, media/buffer preparation equipment etc.), process automation systems (i.e., Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e., SAP. Trackwise, Maximo etc.)
+ Ensure team adherence to Good Manufacturing Practices (GMPs) and standard operating procedures (SOPs)
+ Ensure daily work coordination and distribution as demanded through Bio G schedule to effectively manage production
+ Manage daily communication to shift personnel, support functional team meetings, ensure shift notes are thorough and accurate, and provide shift handover support and critical update summaries to other Shift Supervisors
+ Ensure oversight on critical operations through systematic walk down and checks prior to execution
+ Develop and manage operational schedule in conjunction with scheduling and planning team, recognize cross-functional impact, and capture and communicate any variance to cross-functional groups in real time
+ Act as an area/system owner and point of contact for all work to be carried out in the area over assigned shift
+ Build partnership with assigned Technical Lead to ensure daily data review and trends are accomplished
+ Take active role in selecting and developing team; this includes leveraging relationships internal and external to the SUF manufacturing team to build the best team possible, developing less experienced Technical Leads, and providing general mentorship and training to staff
+ Manage staff performance and prepare performance objectives for mid-year and end-of-year performance connection reviews
+ Drive continuous improvements through staff engagement
Qualifications & Experience
+ Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired
+ 6+ years of direct biologic manufacturing experience, with 2+ years of previous supervisory experience demonstrating proficiency in selection of team and management of personnel highly desired
+ Extensive knowledge of SOPs and cGMPs and their application within a regulatory environment
+ Knowledge of pharmaceutical and biopharmaceutical manufacturing process generally obtained through participation in pharmaceutical technology, technology transfer, process development, and manufacturing support
+ Demonstrated aptitude for engineering principles and manufacturing automation systems
+ Ability to effectively work in a cross-functional, fast-paced, complex, and dynamic environment
+ Effective communication and technical writing skills
#LI-Onsite
#VETERAN
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Locations
Devens - MA - US
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: R1587017
Updated: 2024-11-22 06:14:30.733 UTC
Location: Devens-MA
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