Quality Control Manager

Posted:
9/24/2024, 8:17:11 AM

Location(s):
Massachusetts, United States

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Data & Analytics

Workplace Type:
Hybrid

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.

Bristol-Myers Squibb in Devens, MA, is seeking a remarkable Manager, QC Operations, Bioanalytical to join our QC team. As our Manager, QC Operations, Bioanalytical you'll be responsible for staff in lab area performing testing, analysis, and results reporting of drug substance and drug product Release & Stability samples, for effective operation of the biologics manufacturing facilities at Devens, and our Global Biologics Network. 

*This role works Monday-Friday Day Shift and is 100% onsite*

Role Responsibilities:

  • Responsible for day-to-day operations of the laboratory, including on-time testing, analysis of data and trends, investigations, staff training, and equipment maintenance and calibration. 
  • Develop and supervise staff schedules to meet workflow demands.
  • Perform data review, trending analyses and prepare protocols and reports to support all areas of laboratory operations.
  • Responsible for cGMP compliance in all aspects of assigned laboratory operations.
  • Provide technical and operational expertise for training and developing staff, assisting in troubleshooting.
  • Perform or lead investigations for out of specification results.
  • Recruit and develop a high performing team with diverse backgrounds and talents.
  • Coach direct reports to evaluate and execute continuous improvement, develop their skill sets, and creates an environment of continuous learning, improvement, and innovation.
  • Maintain and communicate team performance metrics.
  • Provide technical leadership to QC lab, serves as Subject Matter Expert in cross-functional / cross departmental work teams, and participates in the site team supporting and managing regulatory inspections and findings.
  • Incumbents have daily interaction with their staff and other members of the site Quality organization. 
  • Supervisors may interact with any employee at any level of the Devens Facility, with daily interactions with other departments on site.  Less frequent contact with general business functions including human resources, EHS, Finance and BMS staff at other locations.

Role Requirements:

  • Knowledge of science generally attained through studies resulting in a BS in physical or life sciences (e.g., chemistry, biochemistry, molecular biology or related discipline) or a combination of education and working experience.
  • Minimum of 4-6 years of experience in a cGMP laboratory with 1-2 years of leadership experience. (ex. group SME, mentorship, project lead).
  • Expertise and operational knowledge of equipment and test methods associated with the following methodologies: Spectrophotometry, Appearance testing and KarlFisher methods.
  • Extensive knowledge of regulatory requirements (e.g., US, EU, USP) and industry best practices. Prior experience supporting regulatory agency inspections preferred.
  • Previous experience with method transfers desired.
  • Experience with LIMS and ELN computer applications a plus.


BMSBL, BMSBLDMA, VETERAN

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 [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.

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.

Bristol Myers Squibb

Website: https://bms.com/

Headquarter Location: New York, New York, United States

Employee Count: 10001+

Year Founded: 1887

IPO Status: Public

Last Funding Type: Post-IPO Debt

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine