Principal Scientist, Aseptic Process Control Sciences
Working with UsChallenging.
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.
Job TitlePrincipal Scientist, Aseptic Process Control SciencesGradeEG-120LocationDevens, MA / New Brunswick, NJDivisionGPS, MS&T, Global Capabilities & Technical StrategyDirect ManagerDirector, Aseptic & Microbial Process Control Sciences, MS&TPosition SummaryThis individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.
The aseptic processing SME will partner with the internal and external manufacturing sites to define strategies for microbial control for DP related manufacturing activities such as gowning, environmental monitoring, media fill program, and will ensure the control strategies comply with Annex 1 and FDA Guidance for Industry.
The individual will interface with the manufacturing plant to support the establishment and maintenance of critical cGMP aseptic activities, and will also support critical manufacturing investigations involving aseptic processing.
This role will closely collaborate with the MS&T Biologics Drug Product / Parenteral team as well as the Microbiology CoE Analytical group.
It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE.
Direct ReportsNoneBusiness Partners & Interactions The Aseptic Processing SME influences and maintains effective collaborations across the BMS network, closely partnering with MS&T Parenteral, Quality, QC, Manufacturing, network Microbiology CoE Analytical, as well as other MS&T partner functions.
This role will interact with Health Authorities.
Position Responsibilities Provide oversight to site media fill programs, including elements such as required operator training and qualification, approach to coverage of all products in the media fill program, use of components, and intervention strategy.
Review and approve annual media fill programs and aseptic validation master plans for new areas for internal sites.
Provide oversight to site gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintenance of the aseptic processing environment.
Provide oversight/input to site sterilization process qualification activities, and review and approve PQ protocols.
Support Tech Transfer activities as needed.
Leadership and/or support of critical manufacturing investigations involving aseptic processing components, including root cause analysis, CAPA generation, and impact assessment.
Act as the point of contact to triage microbial investigations to the appropriate microbiology SME within the network.
Collaborate with the Microbiology CoE Testing group, with the aim to provide process support/expertise to rapid microbiology method development and implementation in the production environment.
Interface with the Biologics Drug Product MS&T group and product specific technical teams to consult on microbial sampling during technology transfers and qualification activities.
Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions.
Technical SME on Quality audit team for External manufacturing sites.
Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing.
Technical input, authoring (when applicable), and approval of CMC documents for process validation P.
3.
5 sections.
Support CMC queries and resolution with Global Health Authorities, and support plant inspections.
Desired ExperienceEducation:
Bachelor's degree or equivalent in relevant engineering or scientific discipline with a minimum of 10 years of relevant experience.
Masters or PhD is preferred (but not required).
Time spent in advanced degree programs may be considered as equivalent relevant experience.
Experience / Knowledge Desired:
Subject matter expert in sterile manufacturing processes and technology, and aseptic processing.
Strong knowledge of global regulatory requirements (e.
g.
FDA) related to the design and control of the aseptic/environmental aspects of these processes.
Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
Experience in sterile manufacturing plant(s) with interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus.
Strong technical writing skills.
Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone, Requires approximately 20% travel Demonstrated ability to:
Influence areas not under direct control to achieve objectives Work strategically, manage multiple programs consistent with department objectives Work well in a matrix environment and effectively support the decentralized manufacturing function Build alignment with business partners including the manufacturing sites, the Micro CoE Testing group Quality stakeholders Manage risk and make rapid decisions Personal Competencies Desired/Required:
Strong strategic and analytical thinking, problem solving and rapid decision making skills Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment Strong ability in negotiating and influencing without authority in complex, high impact situations Strong presentation and communication skills both, oral and written BMS Bio-Pharma Behaviors Required:
Accountability:
We all own BMS' success and strive to be transparent and deliver on our commitments Urgency:
We move together with speed and quality because patients are waiting Innovation:
We pursue disruptive and bold solutions for patients Passion:
Our dedication to learning and excellence helps us to deliver exceptional results Integrity:
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues Inclusion:
We embrace diversity and foster an environment where we can all work together at our full potential 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 email protected .
Visit careers.
bms.
com/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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Analytical Assessments Bacteria Cultures Coaching And Mentoring Communication Complementary Metal Oxide Semiconductor (Cmos) Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Job TitlePrincipal Scientist, Aseptic Process Control SciencesGradeEG-120LocationDevens, MA / New Brunswick, NJDivisionGPS, MS&T, Global Capabilities & Technical StrategyDirect ManagerDirector, Aseptic & Microbial Process Control Sciences, MS&TPosition SummaryThis individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.
The aseptic processing SME will partner with the internal and external manufacturing sites to define strategies for microbial control for DP related manufacturing activities such as gowning, environmental monitoring, media fill program, and will ensure the control strategies comply with Annex 1 and FDA Guidance for Industry.
The individual will interface with the manufacturing plant to support the establishment and maintenance of critical cGMP aseptic activities, and will also support critical manufacturing investigations involving aseptic processing.
This role will closely collaborate with the MS&T Biologics Drug Product / Parenteral team as well as the Microbiology CoE Analytical group.
It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE.
Direct ReportsNoneBusiness Partners & Interactions The Aseptic Processing SME influences and maintains effective collaborations across the BMS network, closely partnering with MS&T Parenteral, Quality, QC, Manufacturing, network Microbiology CoE Analytical, as well as other MS&T partner functions.
This role will interact with Health Authorities.
Position Responsibilities Provide oversight to site media fill programs, including elements such as required operator training and qualification, approach to coverage of all products in the media fill program, use of components, and intervention strategy.
Review and approve annual media fill programs and aseptic validation master plans for new areas for internal sites.
Provide oversight to site gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintenance of the aseptic processing environment.
Provide oversight/input to site sterilization process qualification activities, and review and approve PQ protocols.
Support Tech Transfer activities as needed.
Leadership and/or support of critical manufacturing investigations involving aseptic processing components, including root cause analysis, CAPA generation, and impact assessment.
Act as the point of contact to triage microbial investigations to the appropriate microbiology SME within the network.
Collaborate with the Microbiology CoE Testing group, with the aim to provide process support/expertise to rapid microbiology method development and implementation in the production environment.
Interface with the Biologics Drug Product MS&T group and product specific technical teams to consult on microbial sampling during technology transfers and qualification activities.
Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions.
Technical SME on Quality audit team for External manufacturing sites.
Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing.
Technical input, authoring (when applicable), and approval of CMC documents for process validation P.
3.
5 sections.
Support CMC queries and resolution with Global Health Authorities, and support plant inspections.
Desired ExperienceEducation:
Bachelor's degree or equivalent in relevant engineering or scientific discipline with a minimum of 10 years of relevant experience.
Masters or PhD is preferred (but not required).
Time spent in advanced degree programs may be considered as equivalent relevant experience.
Experience / Knowledge Desired:
Subject matter expert in sterile manufacturing processes and technology, and aseptic processing.
Strong knowledge of global regulatory requirements (e.
g.
FDA) related to the design and control of the aseptic/environmental aspects of these processes.
Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
Experience in sterile manufacturing plant(s) with interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus.
Strong technical writing skills.
Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone, Requires approximately 20% travel Demonstrated ability to:
Influence areas not under direct control to achieve objectives Work strategically, manage multiple programs consistent with department objectives Work well in a matrix environment and effectively support the decentralized manufacturing function Build alignment with business partners including the manufacturing sites, the Micro CoE Testing group Quality stakeholders Manage risk and make rapid decisions Personal Competencies Desired/Required:
Strong strategic and analytical thinking, problem solving and rapid decision making skills Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment Strong ability in negotiating and influencing without authority in complex, high impact situations Strong presentation and communication skills both, oral and written BMS Bio-Pharma Behaviors Required:
Accountability:
We all own BMS' success and strive to be transparent and deliver on our commitments Urgency:
We move together with speed and quality because patients are waiting Innovation:
We pursue disruptive and bold solutions for patients Passion:
Our dedication to learning and excellence helps us to deliver exceptional results Integrity:
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues Inclusion:
We embrace diversity and foster an environment where we can all work together at our full potential 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 email protected .
Visit careers.
bms.
com/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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Analytical Assessments Bacteria Cultures Coaching And Mentoring Communication Complementary Metal Oxide Semiconductor (Cmos) Estimated Salary: $20 to $28 per hour based on qualifications.
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