Associate Director QC Analytical

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Job Information

Bristol Myers Squibb

Associate Director, QC Analytical

in

Devens

Massachusetts

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 is seeking an Associate Director of QC Analytical at the Cell Therapy Facility (CTF) in Devens, MA. This role will be responsible for all operational aspects of the Quality Control Analytical organization at the Devens CTF in support of method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product. This includes managing multiple teams within the Quality Control Analytical department to meet 24x7x365 manufacturing and laboratory schedules. Additionally, this role will directly interface with internal and external stakeholders to deliver exceptional results and drive continuous improvement of the systems and processes used in the Devens CTF QC laboratories.

This individual will be a key leader for the Devens Cell Therapy QC leadership team and a champion for quality principles and compliance within the Devens organization. This role is stationed in Devens, MA and reports to the Director of QC Operations for the Devens Cell Therapy Facility.

Responsibilities:

Direct all activities related to the QC Analytical laboratory operations and support including:

GMP testing and documentation for in-process and drug product release (disposition)

Serving as primary POC and Subject Matter Expert for QC Analytical laboratory functions

Department programs and projects (e.g., Lean Labs) related towards the goal of continuous improvement

Establishing, communicating, and sustaining performance measures consistent with business unit and Quality goals

Analysis and reporting of key metrics and method trending

Method development, validation and transfer

Timely closure of laboratory investigations and associated CAPA within the electronic investigation management system

Participation in regulatory inspections, reviews, and approvals of the facility and products

Manage and develop direct reports through:

Planning appropriate department workforce and structure based on demand plan for cell therapy products

Creating a collaborative environment that attracts, develops, and retains the best talent

Hiring, integrating, and developing high quality talent capable of delivering against the department’s goals and objectives

Management and scheduling of multiple teams with varying functions and goals within the department to meet 24x7x365 manufacturing and laboratory schedules and needs

Ensuring employees are properly trained and qualified to perform their assigned tasks, providing developmental feedback and coaching, and supporting career development of direct reports

Knowledge & Skills:

Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills

Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment

Experience with forecasting, capacity modeling, and resource planning

Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products

Experience with method validation and technical transfer

In depth knowledge of QMS and its application to the QC laboratory

Proficient in common computer software applications. Experience with SAP, LIMS and ELN computer applications a plus.

Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences

Ability to work independently and to collaborate cross functionally to drive operational and quality excellence

Advanced organizational and time management skills

Demonstrated strategic thinking, critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills

Basic Requirements:

Bachelor’s degree required, preferably in Chemistry, Cell Biology, or related science

A minimum of 10 years of relevant work experience required

Demonstrated experience building and leading exceptional teams

Preferred Requirements:

Advanced degree preferred in Chemistry, Cell Biology, or related science

6 years of laboratory management preferred

BMSCART, #Li-Onsite

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

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

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:

R1567550

Updated:

2023-03-12 04:42:19.938 UTC

Location:

Devens,Massachusetts

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com