Senior Manager, Investigations, Cell Therapy
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.
Position SummaryThe Senior Manager, Investigations, leads a team that provides GMP investigation support to the Devens Cell Therapy Manufacturing Facility.
The Devens Cell Therapy Manufacturing Facility is a new facility, and the Senior Manager will build and maintain a team, and maintain & improve processes for investigations, corrective and preventative actions, APQR, and product complaints.
The Senior Manager reports to the Associate Director of Investigations and Compliance within the site Manufacturing Science & Technology (MSAT) department.
Responsibilities include, but are not limited to, the following:
Direct supervision of a team of lead investigators In partnership with Quality Assurance, establishes, maintains, and executes the investigations, CAPA, and product complaints programs In collaboration with Quality Assurance, provides oversight of Investigations/CAPA management to ensure timely and compliant closure Facilitates the lead investigator training & certification program Represents the Site MS&T Investigations team in cross-functional forums & projects Performs review and approval of site and department SOPs Maintains permanent inspection readiness; Actively supports regulatory inspections Interacts with other teams including Manufacturing Operations, Process Support/Engineering, Manufacturing Support, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control Stays current with industry trends and BMS standards and participates in best practice forums consistent with function responsibilities.
Leadership:
Hires, integrates, and develops high quality talent who are capable of delivering against the site & department goals and objectives Defines and enforces performance measures; provides developmental feedback and coaching Creates an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments Supports organizational strategic goals and objectives that are linked to the overall company strategy through analytical & risk-based thinking; Makes recommendations and implements actions to meet strategic goals & objectives Drives the development of efficient, consistent processes, and builds a workplace culture of continuous improvement through strong problem solving/creative skills Identifies and recommends improvements to the organization, processes, procedures, and the Quality Management System Delivers business results through timely, quality, and risk-based decision making and advice REQUIRED COMPETENCIES:
Qualifications and Education Requirements:
Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is required A minimum of 8 years' experience in biopharmaceutical operations with 2
years of prior management experience required Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions required Experience in cell therapy, biologics, or vaccine manufacturing/support required Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations Excellent verbal and written communication skills to allow effective interactions with all levels of the organization and with a work style that is decisive yet approachable Strong priority-setting skills, with exceptional attention to detail and the ability to work on multiple projects at the same time Experience in building and growing an organization into a high performing team Ability to think strategically and to translate strategy into actions Experience with Operational Excellence/Six Sigma and Lean Manufacturing is a plus Experience in product complaints and APQRs is a plus WORKING CONDITIONS (US Only):
Position may require working in Clean-Room manufacturing environment approximately 10% of the time.
Remainder of work is performed in an office environment.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any other job-related duties as requested by management.
BMSCARTVETERAN 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 Attention To Detail Biochemistry Business Process Improvement Cell Therapy Communication 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.
Position SummaryThe Senior Manager, Investigations, leads a team that provides GMP investigation support to the Devens Cell Therapy Manufacturing Facility.
The Devens Cell Therapy Manufacturing Facility is a new facility, and the Senior Manager will build and maintain a team, and maintain & improve processes for investigations, corrective and preventative actions, APQR, and product complaints.
The Senior Manager reports to the Associate Director of Investigations and Compliance within the site Manufacturing Science & Technology (MSAT) department.
Responsibilities include, but are not limited to, the following:
Direct supervision of a team of lead investigators In partnership with Quality Assurance, establishes, maintains, and executes the investigations, CAPA, and product complaints programs In collaboration with Quality Assurance, provides oversight of Investigations/CAPA management to ensure timely and compliant closure Facilitates the lead investigator training & certification program Represents the Site MS&T Investigations team in cross-functional forums & projects Performs review and approval of site and department SOPs Maintains permanent inspection readiness; Actively supports regulatory inspections Interacts with other teams including Manufacturing Operations, Process Support/Engineering, Manufacturing Support, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control Stays current with industry trends and BMS standards and participates in best practice forums consistent with function responsibilities.
Leadership:
Hires, integrates, and develops high quality talent who are capable of delivering against the site & department goals and objectives Defines and enforces performance measures; provides developmental feedback and coaching Creates an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments Supports organizational strategic goals and objectives that are linked to the overall company strategy through analytical & risk-based thinking; Makes recommendations and implements actions to meet strategic goals & objectives Drives the development of efficient, consistent processes, and builds a workplace culture of continuous improvement through strong problem solving/creative skills Identifies and recommends improvements to the organization, processes, procedures, and the Quality Management System Delivers business results through timely, quality, and risk-based decision making and advice REQUIRED COMPETENCIES:
Qualifications and Education Requirements:
Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is required A minimum of 8 years' experience in biopharmaceutical operations with 2
years of prior management experience required Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions required Experience in cell therapy, biologics, or vaccine manufacturing/support required Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations Excellent verbal and written communication skills to allow effective interactions with all levels of the organization and with a work style that is decisive yet approachable Strong priority-setting skills, with exceptional attention to detail and the ability to work on multiple projects at the same time Experience in building and growing an organization into a high performing team Ability to think strategically and to translate strategy into actions Experience with Operational Excellence/Six Sigma and Lean Manufacturing is a plus Experience in product complaints and APQRs is a plus WORKING CONDITIONS (US Only):
Position may require working in Clean-Room manufacturing environment approximately 10% of the time.
Remainder of work is performed in an office environment.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any other job-related duties as requested by management.
BMSCARTVETERAN 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 Attention To Detail Biochemistry Business Process Improvement Cell Therapy Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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