Manager, QC Analytical - Devens, United States - Bristol-Myers Squibb

Description

**Working with Us**

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: .

**Position Summary**

The Manager for QC Analytical (Flow Cytometry) at the Cell Therapy Facility (CTF) will manage the daily operations of the QC Analytical shift, responsible for QC testing (e.g., flow cytometry and analytical) and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug product. The Manager, QC Analytical (Flow Cytometry) will also be responsible for hiring, mentoring, and developing the QC Analytical team to support business operations and employee career development.

Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.

This position directly leads the QC shift and works the following shift schedule: Wednesday to Saturday 4 PM 12 AM.

**Key Responsibilities**

+ Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product.

+ Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved.

+ Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities.

+ Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements.

+ Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.

+ Own and evaluate relevant change controls, investigations, deviations, CAPAs.

+ Hire, mentor, and develop team members to support the business operations and employee career development.

+ Oversee training of the team members.

+ Communicate effectively with management regarding task completion, roadblocks, and needs.

+ Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings.

+ Perform other tasks as assigned.

**Qualifications & Experience**

+ Bachelors degree required, preferably in Chemistry, Microbiology or related science.

+ 6+ years of relevant laboratory work experience, preferably in a regulated environment. The incumbent will be working around biohazardous materials.

+ 2+ years of management and people leader experience.

+ An equivalent combination of education and experience may substitute.

+ Experience with flow cytometry and various bioanalytical techniques (e.g., cell-based assays) and associated equipment.

+ Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.

+ Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.

+ Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.

+ Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.

+ Excellent organizational and critical thinking skills.

+ Advanced problem-solving ability/mentality, technically adept and logical.

+ Advanced ability to communicate effectively with peers, department management and cross-functional peers.

+ Proficient with Excel, Visio, PowerPoint, and other common software applications.

_If you come across a role that intrigues you but doesnt 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 . Visit ) 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.

**Company:** Bristol-Myers Squibb

**Req Number:** R

**Updated:** :09:44.053 UTC

**Location:** Devens-MA

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.