Senior Specialist, Quality Control

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 Senior Specialist will serve as the designated subject matter expert for a number of test methods/processes across multiple products, anticipate and perform complex troubleshooting and problem-solve independently.

This role will own generation of protocols and reports, and other documents aligned with regulatory and corporate guidelines. The Senior Specialist will also represent the department in product review boards and regulatory inspections, both internal and external, and may author responses to regulatory requests.

They will lead transfers, validations, projects, CAPAs, and deviations/investigations, and continuous improvement efforts.

Furthermore, the Senior Specialist will train and mentor others on multiple QC test methods, processes, and procedures and perform other tasks as assigned.

Responsibilities:

• Designated Subject matter expert for a number of test methods/processes across multiple products
• Leads method transfer & validation of in-process, final product, and stability methods
• May own scheduling of assignments in consultation with manager.
• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
• Represent the department in product review boards and regulatory inspections (internal and external audits).
• May author responses to regulatory requests.
• Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts.
• Anticipate and perform complex troubleshooting and problem solving independently.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes and procedures.
• Perform other tasks as assigned.
• Owns and contributes to change controls.
• May act as delegate for laboratory management, as required.
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
• Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation.
• Champion and foster a positive, supportive, and collaborative quality culture.
• Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).

Qualifications

• Bachelor's degree required, preferably in a chemistry, life science, or related discipline with 9+ years relevant experience. An equivalent combination of education and experience, preferably in a regulated environment will be considered.
• Past experience with quality control, preferably with focus on stability
• Hands-on experience on with at least one of the following analyses: mRNA, LNP, Potency assay, Flow Cytometry, PCR, ELISA, and/or HPLC is required
• Good understanding with cGMP, GDP and GLP regulations and guidelines
• General experience in data analysis and statistical evaluation/data trending
• Scientific knowledge and direct experience with analytical method transfer processes
• Advanced technical writing skills and problem-solving ability
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
• Communicate effectively with peers, and demonstrate collaboration across different functional groups
• Detail-oriented in assay execution and documentation

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:

Cambridge - MA - US: $122,470 - $148,402

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 https://careers.bms.com/life-at-bms/.

Benefit 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 holidays

Based 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: The 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 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 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 adastaffingsupport@bms.com. 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: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any 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 TAEnablement@bms.com. 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.

R1605098 : Senior Specialist, Quality Control