Bristol Myers Squibb Company

Senior Specialist, Manufacturing Compliance - Cell Therapy

Location
Celgene, NJ, United States
Posted
Sep 02, 2020
Ref
R1529317
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.

PURPOSE AND SCOPE OF POSITION:

The Manufacturing Compliance Senior Specialist, CAR T is responsible for serving as a key contributor in operational compliance on non-conformance events, investigations, batch record management, corrective and preventive actions (CAPA) and change management for the Warren Clinical Manufacturing Team

DUTIES AND RESPONSIBILITIES:
  • Completing / reviewing routine manufacturing nonconformance / deviation investigations
  • Reporting / monitoring metrics on non-conformance investigations, corrective and preventive actions
  • Defining and implementing effective CAPAs to improve compliance and manufacturing success
  • Representing the department in cross functional teams in support of process improvement initiatives
  • Owning change controls and action items for changes impacting manufacturing as needed
  • Ability to respond with a high degree of urgency to departmental and cross functional needs and requests
  • Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
  • Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports
  • Executing revisions to master batch records / protocols / procedures, etc., as deemed necessary for process changes / improvements / new product introductions.
  • Perform gap assessments and ensure compliance with current Data Integrity regulations, guidance, etc.
  • Perform internal audits collaboratively with QA to ensure inspection readiness within facility.


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • Intermediate knowledge of GMP guidance and regulations, particularly those pertaining to GMP training, personnel, and documentation practices.
  • Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
  • Advanced skills in using Microsoft Word, PowerPoint and Excel and a high level of organizational and time management skills.
  • Capability of providing input within the department and cross functional teams
  • Building relationships internally and externally as applicable
  • Contributing to goals within the team and overall manufacturing operations structure
  • Ability to prepare written communications to management with clarity and accuracy
  • Ability to effectively multi-task and execute project management skills
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment.


Education:
  • Bachelor's degree or higher in Life Sciences or engineering or equivalent in work experience. Master's degree preferred


Experience:
  • 6+ years of work experience in the pharmaceutical / biopharmaceutical industry required.
  • Cell therapy experience a plus
  • 4+ years in a GMP setting
  • 2+ Years' experience with CAPAs, investigations, and/or change controls


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.