Associate Director, Biologics Quality Control Analytical Operations

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