Senior Manager, Sterility Assurance Summit West - NJ - US R1596592 Posted 21 hours ago
$121.07k - $146.7kBristol-Myers Squibb
- # Senior Manager, Sterility AssuranceSummit West - NJ - USFind out how well you match with this 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. 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 Summary**The Sr. Manager, Sterility Assurance, is a highly critical role and is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site. This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site. The Sr. Manager Sterility Assurance is responsible to act as the SME during regulatory inspections.**Duties/Responsibilities*** To support final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems.* Development and management of SOPs, forms, and methods required to support the compliant operation.* The Senior Manager, Sterility Assurance plays a critical role in ensuring the execution and support of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs. Generates, owns, and/or supports change controls, deviations, CAPAs within the eQMS system.* Support equipment, facility, and microbiological method qualifications.* Ensure the site and department objectives are met.* Manage and develop direct reports.* Onboard new materials required to support manufacturing operations.* Support manufacturing schedule and needs.* Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations, and support career development of direct reports.* The incumbent will be required to gown for entry into Aseptic core and supporting areas, on an as-needed basis.* The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.* 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.* Occasional travel may be required.* Perform other tasks as assigned.**Qualifications*** Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of cell therapy products.* Advanced data integrity knowledge and practices.* Intermediate understanding of statistics, control charts, action and alert limits and data trending.* Advanced knowledge of Microbiology.* Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc.* Advanced verbal and written communication skills.* Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.* Must be team-oriented and has the demonstrated ability to work cross[1]departmentally throughout the manufacturing site.* Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.* Advanced mentoring and coaching, influencing, negotiating and personal interaction skills.* Demonstrated resource management and planning skills.* Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.* Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.* Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc.* Microbiology laboratory and/or Environmental Monitoring setting.* Experience working with cell therapy products is preferred.* 2-3 years of leadership/managerial experience required.* Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc.* Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.* An equivalent combination of education and experience may substitute*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.*******Compensation Overview:******Summit West - NJ - US: $121,070 - $146,703 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. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:* **Health Coverage:** Medical, pharmacy, dental, and vision care.* **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).* **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.**Work-life benefits include:**Paid Time Off* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidaysBased on eligibility\*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.***\*Eligibility Disclosure:** *T*he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.***Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through scienceTM ”, 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 a supportive culture, promoting global participation 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 an 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.**Supporting People with Disabilities**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 View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.**Candidate Rights**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: Protection**We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1596592 : Senior Manager, Sterility Assurance
- J-18808-Ljbffr Bristol-Myers Squibb
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Manager, Sterility Assurance Summit West - NJ - US R1596592 Posted 21 hours ago in Summit, NJ vacancy
$88.85k - $107.67k
## Manager, CAR-T Site Materials Buying... ...PlanningSummit West - NJ - USFind out... ...**Working with Us** Challenging.... ...Planning and Supply Assurance*** Lead the... ...Overview:******Summit West - NJ - US:... ...Exempt, Non-Exempt, Hourly Employees: 160... ...that the job posting is missing information...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Bristol Myers Squibb is seeking a Senior Manager, Sterility Assurance, to lead the contamination control strategy for the CAR T manufacturing site. The role supervises aseptic process validation, gowning, critical utilities, and validation programs, acting as SME during...Senior
- Bristol-Myers Squibb is looking for a Senior Manager, Sterility Assurance in Summit, NJ. This pivotal role will manage the Sterility Assurance for our CAR T manufacturing site, ensuring compliance with regulatory standards while overseeing aseptic process validation and...SeniorFlexible hours
$122.91k - $148.94k
...Working with Us Challenging. Meaningful.... ...Therapy team. The Senior Project Manager, Cell Therapy Business... ...Compensation Overview: Summit West - NJ - US: $122,910 - $148... ...Exempt, Non-Exempt, Hourly Employees: 160 hours... ...believe that the job posting is missing...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workMonday to FridayFlexible hoursShift workDay shiftBristol-Myers Squibb
Summit, NJ2 days ago$179k - $234k
Senior Treasury Relationship Manager - Government Banking - NJ The Senior Treasury Relationship Manager will... ...entities that bank with us. The role is focused on... ...with office presence in Summit or remote, and a... ...preferred but not required Hours & Work Schedule Hours...SeniorWork at officeLocal areaRemote workFlexible hours- Working with Us Challenging. Meaningful. Life-changing... ...Cell Therapy Account Management Team and US Hematology... ...Meetings This Senior Manager position is a headquarters... ...: Madison - Giralda - NJ - US: $148,750 - $180,2... ...Exempt, Non-Exempt, Hourly Employees: 160 hours...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeImmediate startRemote workFlexible hoursShift work
$96k - $128k
Location On-Site, Morristown, NJ; Portsmouth, NH; or Walkersville, MD (East Coast locations... ..., 8:00 AM - 5:00 PM (Standard Business Hours). We are seeking a high-caliber professional to join our global team as the Senior Manager, US Retirement Benefits . Reporting to the...SeniorFull timeRelocation packageMonday to FridayFlexible hours- The CENTURY 21 Real Estate Marketing Team is looking for a Sr. Manager, Franchise Marketing. This individual will collaborate with the Brand, Growth, and Franchise Sales teams to create and implement marketing strategies aimed at attracting and nurturing potential franchise...Senior
$2,314 per week
...Registered Nurse (RN) | Case Manager Location: Summit, NJ Agency: Prime Staffing Pay: $2,314 per week Shift Information: Days - 3 days x 12 hours Contract Duration: 13 Weeks Start Date: 9/14/2026 About the Position About the Position...Full timeContract workShift workPrime Staffing
Summit, NJ1 day ago$119.7k - $137.7k
Senior Manager, Launch, Global Value Stream (US)About the Role: What's in the BoxThe Senior Manager, Launch is a critical... ...and operational performance.Drive post-launch stabilization, ensuring... ...Range$119,700—$137,700 USDNewark, NJ Pay Range$136,710—$158,100 USDIllinois...SeniorFor contractors- ...KPMG is currently seeking a Tax Manager or Senior Manager to join our... ...servicesProvide R&D tax credit quality assurance, engagement reviewer and exam... ..., standard work hours, and years of service, KPMG provides... ...towards the bottom of our KPMG US Careers site at Benefits & How...SeniorLocal area
$173.39k - $210.11k
## Senior Manager, Global Clinical Scientist - PsychiatryMadison - Giralda - NJ - USFind out how well you match with this job**Working with Us** Challenging. Meaningful. Life-changing... ...to pharma (post fellowship/ new to... ...Exempt, Non-Exempt, Hourly Employees: 160 hours...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Bristol-Myers Squibb in Summit, NJ is seeking a Manager, CSV Cell Therapy to support manufacturing and laboratory systems. Responsibilities include maintaining validated equipment, managing projects, and ensuring compliance with regulatory standards. The ideal candidate...
- Universal Hospital Services Inc. is looking for a Psychiatrist in Summit, NJ. The role involves providing diagnostic and therapeutic care for... ...competitive compensation, generous paid time off, medical/dental/vision plans, and a 401(K) match. #J-18808-Ljbffr Jobleads-USSenior
$149.28k - $237.36k
...and transformation. The Senior Manager, Finance Transformation... ...can sit in any of our US office locations and offers... ...a hybrid schedule with hours from 9:00 AM to 5:30 PM... ...which this position is posted and who apply for this... ...Alto, CA; Short Hills, NJ; Minneapolis, MN;...SeniorFull timeWork at officeRemote workRelocationVisa sponsorshipRelocation package$164.11k - $198.86k
...Working with Us Challenging. Meaningful. Life-changing... .... Position Summary The Senior Manager of Biostatistics is a... ...Madison - Giralda - NJ - US: $164,110 - $198,8... ...Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours... ...believe that the job posting is missing information...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workBristol-Myers Squibb
Madison, NJ14 hours ago$120k - $145k
...Role This position reports to the Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract... ...for drug production Strong knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111) Strong leadership...SeniorContract workFlexible hoursBreckenridge Pharmaceutical Inc
Berkeley Heights, NJmore than 2 months ago$133k - $168k
...thinking and collaboration. Position Summary Senior Manager, Consumer Brand Marketing (Huntington’s... .... A hybrid position based in Parsippany, NJ, with 2‑3 days onsite each week.... ...federal, state, or local laws. Please advise us of any accommodations needed throughout the...SeniorLocal areaWorldwideFlexible hours2 days per week3 days per weekTeva Pharmaceuticals
Parsippany, NJ4 days ago$119.7k - $137.7k
Senior Manager, Launch, Global Value Stream (US) About the role: What's in the Box The Senior Launch Manager is a critical... ...launch processes, creating post-mortem reports and implementing lessons... ...Range $119,700—$137,700 USD Newark, NJ Pay Range $136,710—$158,100 USD...SeniorFor contractorsImmediate startFlexible hours$90 - $100 per hour
...and Knowledge Management. Custom Development... .... Seniority level Executive... ...2x Additional postings New York, NY $1... ...,000.00 1 week ago New York, NY $1... ...Woodcliff Lake, NJ $160,000.00-$17... ...$150,000.00 11 hours ago New York, NY... ...0 18 hours ago Summit, NJ $125,000.00...SeniorContract work- ...Description The Senior Manager of Managed Care... ...certified. About Us At Atlantic... ...Center, Morristown, NJ Atlantic Health... ...Medical Center, Summit, NJ Atlantic Health... ...Coverage (22.5 hours per week or above... ...1, 2025), all job postings will include the hourly...SeniorHourly payDaily paidFull timeContract workTemporary workPart timeFor contractorsFor subcontractorFlexible hoursShift work
Atlantic Health
Morristown, NJ20 days ago $21 - $23.5 per hour
...Job Description Assistant General Manager - Middlesex County, NJ ABOUT HONEYGROW honeygrow is a... ...that truly propels and differentiates us in becoming a sustaining, great... ...or agency. Pay or shift range: $21 - $23.50 per hour The estimated range is the budgeted...Hourly payCasual workWork at officeShift workNight shiftHoneygrow LLC
Avenel, NJ3 days ago$120k - $145k
...In 2026, Newsweek named us one of America's... ...retirement, and wealth management products and services.... ...We are looking for a Senior Account Executive to join... ...able to work from both NJ and NYC offices. Job... ...analysis as needed. * Assure proper disposition of items...SeniorWork experience placementInternshipLocal areaFlexible hoursHUB International
Berkeley Heights, NJ14 hours ago- ...seeking the best and brightest talent to help us bring cutting edge technology to mission... ...seeking an experienced and strategic Quality Manager to lead Mission Assurance and Quality operations across our West Caldwell, NJ, Saddle River, NJ, and Huntsville, AL manufacturing...Casual workWorldwide
- ...for as a firmKPMG is currently seeking a Senior Manager to join our Mergers & Acquisitions practice... ...on job classification, standard work hours, and years of service, KPMG provides Personal... ...be found towards the bottom of our KPMG US Careers site at Benefits & How We Work....SeniorLocal area
$96k - $128k
Senior Manager, US Retirement BenefitsLocation: On-Site, Morristown, NJ; Portsmouth, NH; or Walkersville, MD (East Coast locations; flexible on final site placement).... ...– Friday, 8:00 AM – 5:00 PM (Standard Business Hours).We are seeking an experienced total rewards leader...SeniorFull timeContract workLocal areaMonday to FridayFlexible hours$153.43k - $332.7k
...for as a firm.KPMG is currently seeking a Senior Manager to join our International Tax practice.... ...Depending on job classification, standard work hours, and years of service, KPMG provides... ...be found towards the bottom of our KPMG US Careers site at Benefits & How We Work.Follow...SeniorTemporary workLocal area$149.28k - $227.47k
...Pursuits & Directories Senior Manager, working in collaboration... ...updated consistently post-pitches.Prepares unique... ...Flexibility to adjust hours to meet client-driven deadlines... ...please contact careers@us.dlapiper.com. Agency... ..., TX; Short Hills, NJ; Minneapolis, MN; Chicago...SeniorFull timeWork at officeRemote workRelocationVisa sponsorshipRelocation package$72k - $184.44k
...people in audit and assurance focus on... ...governance and risk management processes and related... ...clients. As a Senior Associate, you... ...150 credit hours for the Certified... ...RequirementsUp to 40%Job Posting End DateThe... ...; MA-Boston; US-Hybrid; NY-New York; NJ-Florham Park; CA...SeniorFull timeH1bWork at office$105.64k - $223.1k
...for as a firm.KPMG is currently seeking a Manager or Senior Manager - Renewable Energy Credits (AMCS... ...on job classification, standard work hours, and years of service, KPMG provides Personal... ...be found towards the bottom of our KPMG US Careers site at Benefits & How We Work....SeniorWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager, Sterility Assurance Summit West - NJ - US R1596592 Posted 21 hours ago. Be the first to apply!
