Bristol Myers Squibb Technical Documentation Specialist, Cell Therapy in Devens, Massachusetts
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:
BMS Cell Therapy Manufacturing seeks Technical Documentation Specialists within Manufacturing that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work collaboratively with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support the creation, revision and approval of all procedures for Cell Therapy operations.
DUTIES AND RESPONSIBILITIES:
Author Standard Operating Procedures (SOP) and Master Batch Records (MBR) for the manufacture of cell therapy in accordance with Current Good Manufacturing Practices (cGMP’s).
Develop internal controls and policies to ensure that all compliance needs are met
Work closely with department SME’s to review all departmental policies for compliance alignment
Accountable for ensuring full quality and regulatory compliance of Manufacturing GMP documentation.
Work as a liaison between manufacturing and Quality Operations and relevant Management systems.
Serve as a resource for Tech Transfer
Assist with Tech Transfer and Manufacturing Risk Assessment and Mitigation evaluation activities.
Communicates to all functional area managers and supervisor Quality related initiatives and actions.
Must have the ability to challenge and make recommendations
Escalate compliance concerns to management in a timely manner
The ability to review and approve change controls as the manufacturing representative
Ensure high levels of communication with team, support resources and management regarding issue identification and resolution
Other duties as assigned
- Bachelor’s Degree in a related field required
5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, cGMP knowledge, and production operations
5+ years in a Manufacturing/Operations in a cGMP environment is required
An equivalent combination of education, experience and training may substitute.
Cell Therapy manufacturing experience preferred.
Ability to work by influencing peers and gain their cooperation; working collaboratively
Incumbents act with very limited supervision for routine activities to determine methods and procedures on new assignments
A high sense of urgency and a commitment to delivering results is essential.
Advanced time management skills, including ability to prioritize and manage expectations
Advanced proficiency in Microsoft Office
Advanced technical writing skills
Advanced knowledge of GMP manufacturing and regulations
Intermediate knowledge of qualification and validation requirements in a regulated environment
Basic presentation development and delivery skills
Ability to provide accurate estimates and effectively communicate status of deliverables
Ability to gown into Grade C and D classified environments
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.
Company: Bristol Myers Squibb
Req Number: R1536777-en-us
Updated: 2021-02-25 00:47:16.634 UTC
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.
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