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.

Position Summary

This position supports Biologics Quality Control (QC) testing within the BioSeparations, STAT, BioAssay, and BioAnalytical teams.  This role is also responsible for QC Training and data administration/maintenance of the Smart QC program.  Principle objectives are to direct the development, implementation and refinement of standards, methods, procedures, laboratory facilities and daily operations for testing and reporting of in process, final bulk, and stability samples in accordance with cGMP and Company SOPs.

Key Responsibilities

• Directs the daily operation of a biologics QC department testing and reporting of BioSeparations, STAT, BioAssay, and BioAnalytical samples to support the manufacturing of bulk drug substance.

• Directs QC Training to maintain the Door to Floor program and strategically enhance specific training programs for each area within Analytical Operations. 

• Defines departmental roles and accountabilities. Nurture top-tier talent who can effectively achieve the department's goals and objectives while maintaining a strong commitment to compliance.

• Establishes and communicate performance objectives for QC staff that are consistent with the business unit and Quality goals. Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment that attracts, develops, and retains the best talent.  

• Participates in/owns audit response development and management of response timeline and CAPA identification.

• Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.

• Represents Devens site QC on network/above-site governances and initiatives (e.g., Commercial Analytical Portfolio Review, Business Continuity Management, etc.).

• Accountable for on time, quality laboratory investigations and associated CAPA within the electronic investigation management system (e.g. Infinity), as needed.

• Drives work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. 

• Exercises sound judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. 

Qualifications & Experience

• Minimum BS degree with 10+ years relevant life-science industry experience (pharmaceutical/biologics) or related subject in a QC environment.

• In depth knowledge of biologics laboratory settings, common QC procedures, techniques, and laboratory equipment/instrumentation, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, CFR). 

• Demonstrated leadership, interpersonal, communication, and motivation skills.

• Experience leading and managing a large, multi-leveled organization is essential.

• Knowledge of biotech bulk and finished product manufacturing and analytical testing is highly desirable.

• Extensive knowledge of US and EU cGMP regulations and guidance.

• Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.

• Demonstrated ability to escalate emerging compliance issues to site-level leadership.

• Proficient understanding of Quality Assurance principles as they can be applied to QC.

• Ability to work collaboratively with all employees at all levels.

• Strong understanding/knowledge of Sample Manager, LES, Empower and Infinity preferred.

• Proficiency in Windows Server 2000, Windows 2003 Server.

• Strong project management, problem-solving and decision-making skills.

• Ability to perform well in a team-based environment, creating inclusive environment.

• Experience determining objectives of significant projects or assignments.

#BMSBL

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/

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