Sr. Specialist, Manufacturing - Bristol Myers Squibb
Phoenix, AZ
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 .
Day shift- flexible -8am- 5pm or 6am-2pm , 7am-3pm.
Education and Experience
+ Relevant college or university degree preferred
+ 5 years relevant work experience required, preferably in a pharmaceutical environment.
+ An equivalent combination of education and experience acceptable.
Required Competencies: Knowledge, Skills, and Abilities
+ Intermediate proficiency in MS Office Suite applications.
+ Intermediate knowledge of cGMP for a controlled manufacturing area.
+ Intermediate trending analysis skills to include compilation, sorting and reporting
+ Intermediate understanding of Validation concepts and principals.
+ Advanced critical thinking and decision making skills.
+ Advanced time-management, organizational, and multi-tasking abilities
+ Advanced written and verbal communication skills.
+ Ability to solve routine and complex problems.
+ Ability to interpret / write technical documents.
+ Ability to work independently for extended periods of time.
+ Ability to lead a cross-functional, technical team to support site/departments projects.
+ Ability to conduct and document deviation investigations and change controls.
Duties and Responsibilities
Provides support to Manufacturing Operations within the appropriate GMP system.
+ Deviation/Investigation
+ CAPA
+ Change Control
+ Protocol
+ SOP revision/creation
+ Works with Manufacturing Management to ensure compliance with cGMPs, SOPs and policies.
+ Collaborates with Manufacturing Management to support/lead initiatives to improve the manufacturing process.
+ Lead cross functional investigative teams deploying specific investigative principles as necessary to ensure root cause analysis and corrective action(s)
+ Ensures corrective actions and improvements are shared and incorporated into the appropriate process.
+ Provides feedback to Manufacturing Management and support groups in relation to findings during deviation investigations.
+ Generate, manage and execute CAPA and Change Control documents to support response to deviations, audit findings and independent corrective actions.
+ Generate and execute change notice to support SOP, Work Practice and Program revision and maintenance.
+ Compile department and site trending information for evaluation.
+ Develop, implement and maintain applicable department/site programs.
+ Serve as an SME for various systems during internal, external and regulatory audits.
+ Performs all other tasks as assigned.
Working Conditions
+ Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time.
+ Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
+ The incumbent must be able effectively communicate deviation/investigation results to the senior leadership within the site on a weekly basis.
+ The incumbent must be able to gown to Grade A, B, C and D requirements. This requires the ability to bend and move to gown aseptically.
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: R1588324
Updated: 2025-01-15 04:19:37.896 UTC
Location: Phoenix-AZ
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 .
Day shift- flexible -8am- 5pm or 6am-2pm , 7am-3pm.
Education and Experience
+ Relevant college or university degree preferred
+ 5 years relevant work experience required, preferably in a pharmaceutical environment.
+ An equivalent combination of education and experience acceptable.
Required Competencies: Knowledge, Skills, and Abilities
+ Intermediate proficiency in MS Office Suite applications.
+ Intermediate knowledge of cGMP for a controlled manufacturing area.
+ Intermediate trending analysis skills to include compilation, sorting and reporting
+ Intermediate understanding of Validation concepts and principals.
+ Advanced critical thinking and decision making skills.
+ Advanced time-management, organizational, and multi-tasking abilities
+ Advanced written and verbal communication skills.
+ Ability to solve routine and complex problems.
+ Ability to interpret / write technical documents.
+ Ability to work independently for extended periods of time.
+ Ability to lead a cross-functional, technical team to support site/departments projects.
+ Ability to conduct and document deviation investigations and change controls.
Duties and Responsibilities
Provides support to Manufacturing Operations within the appropriate GMP system.
+ Deviation/Investigation
+ CAPA
+ Change Control
+ Protocol
+ SOP revision/creation
+ Works with Manufacturing Management to ensure compliance with cGMPs, SOPs and policies.
+ Collaborates with Manufacturing Management to support/lead initiatives to improve the manufacturing process.
+ Lead cross functional investigative teams deploying specific investigative principles as necessary to ensure root cause analysis and corrective action(s)
+ Ensures corrective actions and improvements are shared and incorporated into the appropriate process.
+ Provides feedback to Manufacturing Management and support groups in relation to findings during deviation investigations.
+ Generate, manage and execute CAPA and Change Control documents to support response to deviations, audit findings and independent corrective actions.
+ Generate and execute change notice to support SOP, Work Practice and Program revision and maintenance.
+ Compile department and site trending information for evaluation.
+ Develop, implement and maintain applicable department/site programs.
+ Serve as an SME for various systems during internal, external and regulatory audits.
+ Performs all other tasks as assigned.
Working Conditions
+ Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time.
+ Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
+ The incumbent must be able effectively communicate deviation/investigation results to the senior leadership within the site on a weekly basis.
+ The incumbent must be able to gown to Grade A, B, C and D requirements. This requires the ability to bend and move to gown aseptically.
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: R1588324
Updated: 2025-01-15 04:19:37.896 UTC
Location: Phoenix-AZ
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