Technical Documentation Specialist (R1559601-en-us)
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 seeking a Technical Documentation Specialist 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.
DUTIES AND RESPONSIBILITIES:
- Author and revise Standard Operating Procedures (SOP), Master Batch Records (MBR), and associated documentation for the manufacture of Cell Therapy products in accordance with Current Good Manufacturing Practices (cGMP’s).
- Work closely with department SME’s to develop internal controls and departmental policies to ensure compliance alignment
- Accountable for ensuring full quality and regulatory compliance of Manufacturing GMP documentation.
- Work as a liaison between Manufacturing, Process Engineering and Quality Operations.
- Assist with Tech Transfer and Manufacturing Risk Assessment and Mitigation evaluation activities.
- Communicates/escalates quality and compliance related initiatives, actions, and concerns to functional area managers in a timely manner.
- Must have the ability to challenge and make recommendations.
- Review and approve change controls and other technical documents as the manufacturing representative.
- Ensure high levels of communication with team, support resources and management regarding issue identification and resolution.
- Supports Deviation Investigations, CAPAs, and Change Controls as required.
- Functions as a Subject Matter Expert for Cell Therapy Manufacturing processes.
- Tracks deliverables and manages timelines effectively.
- Other duties as assigned.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- A Bachelor’s Degree in a related field is preferred. A combination of education and relevant experience may be considered in lieu of degree.
- 3+ years in a Biotechnology/Pharmaceutical Manufacturing Operations or Support role. cGMP knowledge is required.
- An equivalent combination of education, experience and training may substitute.
- Experience authoring cGMP documentation is preferred.
- Cell Therapy manufacturing experience preferred.
- Ability to work by influencing peers, 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 cGMP manufacturing & 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
- Someone who innovates to come up with creative solutions to complex problems
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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