Bristol Myers Squibb Company

Sr. Supervisor Quality Control

Location
Bothell, WA, United States
Posted
Sep 15, 2020
Ref
R1529866
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

This is a Wednesday - Saturday PM Shift (1:30p - midnight)

PURPOSE AND SCOPE OF POSITION:

The QC Supervisor of will be responsible for the day to day operations associated with the in-process, release, and stability testing of clinical and commercial autologous cell therapy product. The QC Supervisor will be a key leader responsible for GMP operations and meeting critical business goals.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:
  • BS in a scientific discipline.

Experience
  • 8+ year of regulated industry experience or equivalent combination of education and experience.
  • Minimum of 2 years leadership experiences including the management of direct reports required.


Knowledge, Skills, and Abilities
  • Strong working knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
  • Demonstrated experience building and leading exceptional teams
  • Ability to apply Lean, Six Sigma and Risk Management concepts and tools is preferred.
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
  • Demonstrated success working in a high-performing, business results-driven environment.


DUTIES AND RESPONSIBILITIES:

Key Responsibilities
  • Provide supervision of Quality Control (QC) associates and oversees the day to day activities related to in-process, final release and stability testing of drug product.
  • Develops and manages a daily work plan for QC associates.
  • Hire, mentor and develop exceptional QC personnel.
  • Identifies and mitigates risks in QC labs that could negatively impact the safety, identity, strength purity or quality of the product.
  • Assists in the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
  • Provides leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product.
  • Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
  • Analyze trends and generate metrics using statistical analysis.


WORKING CONDITIONS (US Only):
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
  • Work in areas that may have strong magnets.
  • May work in areas with exposure to vapor phase liquid nitrogen.
  • Must have ability to work assigned shift (Day, Night, Weekends and/or holidays).
  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
  • Require to work in and around laboratories and controlled, enclosed, restricted areas, included clean rooms.
  • Require to carry and/or lift up to 10 pounds several times a day


This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.