Bristol Myers Squibb Senior Manager, MES Project Lead in Cambridge, 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.
BMS Cell Therapy seeks a Sr. Manager that brings leadership, enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and a subject matter expert in electronic manufacturing batch records.
The Sr. Manager leads a team of specialists owning manufacturing electronic batch records. They provide input to the design, recipe development and are responsible for change management for the site manufacturing electronic batch records (MES). The Sr. Manager works with Digital Plant, IT, Manufacturing Operations and process subject matter experts to deliver changes to MES recipes. The position requires excellent project management skills and coordination with stakeholders. The position acts as a team lead for the department and reports to the Director of Cell Therapy Manufacturing Technology.
DUTIES AND RESPONSIBILITIES:
Manage team of project leads responsible who apply their process expertise and electronic batch record technical knowledge to own electronic batch record changes and the associated change controls.
Own Electronic Batch Record (MES/Syncade) Functional specifications. Ensure consistent execution of recipe modifications and changes. Ensure adherence with governing documents related to change management.
Establish and maintain internal procedures for maintaining electronic batch records in accordance with GxP regulatory requirements and internal standards.
Ensure team of project leads works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MS&T to ensure change initiatives are driven to closure, and migrated to the production area in a timely manner. Ensure changes are delivered with proper training to the floor (all shifts as needed)
Owns the lifecycle of an electronic batch record change
Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development.
Understanding of MES library objects. Use that understanding to direct changes to MES recipes and/or directly update the MES recipes utilized in Manufacturing.
Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.
Execute testing of the recipes in the development environment to ensure functionality.
Manage User Acceptance Testing process for recipe qualification.
Provide technical support by troubleshooting and resolving MES issues to support manufacturing operations.
Develop and deliver reports from reporting software.
Provide Audit support as needed, as a technical SME of the process, facility, and operational recipes.
Able to use creative problem solving. Provides technical expertise to management and less experienced professionals.
Perform other tasks as assigned.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education and Experience
Bachelor’s degree in a related field from an accredited college or university required.
Minimum of 8 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.
Minimum of 2 years of people management experience required
Strong project management skills are needed. 2 years of experience with project coordination and cross-functional team leadership preferred.
2 years of experience supporting electronic batch records, preferably Syncade MES.
Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.
The incumbent will be required to gown to access classified manufacturing areas.
Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability.
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.
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.
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 any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1541553
Updated: 2021-06-14 02:57:01.025 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.
Bristol Myers Squibb
- Bristol Myers Squibb Jobs