Manufacturing Specialist, Technical Documentation, Cell Therapy Manufacturing in Devens, MA
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Job Location:
Devens, MA - USA
Monthly Salary:
$ 43 - 53
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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: Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.
Bristol Myers Squibb Cell Therapy Manufacturing is seeking a Specialist Technical Documentation Cell Therapy Manufacturing who can bring 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 passionate and innovative individuals with a strong understanding of current good manufacturing practices to support the creation revision and approval of all procedures and related documentation for Cell Therapy operations.
BMS Values
- Our values move us toward our mission to discover develop and deliver innovative medicines that help patients prevail over serious diseases.
- Candidates must exemplify the BMS values of Passion Integrity Inclusion Accountability Innovation and Urgency:
Passion
- Demonstrate dedication to quality and accuracy in documentation understanding the critical role these play in advancing patient care
- Engage with team members and SMEs to support shared goals with enthusiasm and commitment
Urgency
- Performs functions following all SOPs and compliance standards.
- Supports manufacturing in meeting deadlines for documentation updates.
Innovation
- Support process improvement initiatives identifying opportunities to improve GMP documentation and close compliance gaps
- Able to propose new ideas or methods to streamline document creation and compliance.
Accountability
- Take responsibility for assigned tasks from initiation to completion consistently meeting deadlines and quality standards.
- Own documentation workflows and associated quality actions and drive to completion.
Integrity
- Exhibit attention to detail by ensuring documentation is accurate and adheres to regulatory guidelines internal policies and ethical standards.
- Maintain compliance through diligent adherence to established procedures escalating concerns when necessary.
Inclusion
- Collaborates cross-functionally and contributes to a culture of inclusion and diversity.
Shifts Available:
Monday - Friday 8am - 4pm
Responsibilities:
- Author and revise Standard Operating Procedures (SOP) and associated documentation for cell therapy manufacturing in accordance with Current Good Manufacturing Practices (cGMPs).
- Work closely with department SMEs to align on procedural updates tech transfers and ensure proper reviewers/approvers on all documentation
- Accountable for ensuring quality and regulatory compliance of Manufacturing GMP documentation.
- Work as a liaison between manufacturing Quality Operations and relevant Management systems.
- Assist with Tech Transfer activities.
- Communicate to all functional area managers and supervisors Quality-related initiatives and actions.
- Must have the ability to challenge and make recommendations.
- Escalate compliance concerns to management in a timely manner.
- Review and approve change controls as the manufacturing representative.
- Communicate with team support resources and management regarding issue identification and resolution.
- Develop solid understanding of quality and documentation systems (BMSDocs and Infinity)
- Identify manage and own quality actions as required.
- Develop solid understanding of Cell Therapy Manufacturing processes.
- Tracks deliverables and manages timelines effectively.
- Supports internal/external audits taking urgent action to support requests.
- Assist with team metrics identifying improvements & ensuring prompt action is taken.
- Obtain access to and develop solid understanding of various electronic systems utilized by Manufacturing (MES SAP ValGenesis DeltaV Maximo etc.).
Minimum Requirements:
- Education: A Bachelors Degree in a related field is preferred. A combination of education and relevant experience may be considered in lieu of degree.
- Experience: 3 years in a Biotechnology/Pharmaceutical Manufacturing Operations or Support role. Knowledge of cGMP and manufacturing production is preferred. Experience authoring cGMP documentation and Cell Therapy manufacturing experience is preferred.
BMSCART
#LI-ONSITE
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more
