Associate Director, Cell Therapy Manufacturing Systems & MES (R1549599-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:
The Associate Director – Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at multi‐use sites through interaction with internal team members, peer and higher level customers as well as external service providers. This role will supervise junior and experienced level professionals to maintain system performance and up-time and lead short‐term and long-term IT projects according to established policies and procedures. The individual is responsible for development of and adherence to system governance procedures. The individual manages multiple IT projects and ongoing work activities of moderate to high complexity to ensure on time completion. In addition to answering questions and resolving IT issues for staff, the incumbent spends a small portion of their time on individual work.
Reporting into the IT organization the candidate will be primarily responsible for driving solutions to manufacturing system related problems including reviewing, planning, building, testing, documenting, and implementing design changes. The candidate should have at least 10 years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The applicant needs to have a strong grasp of shop floor activities, Good Manufacturing Practices (GMPs), and process automation in addition to prior experience in Manufacturing Execution System (MES) implementation and corresponding Enterprise Resource Planning (ERP) system integrations, preferably Emerson Syncade, Distributed Control System implementation (DCS), preferably Emerson DeltaV and Historian implementation, preferably OSIsoft PI System.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Ability to effectively communicate with upper management and site leadership.
- Ability to effectively communicate with both technical and non-technical team members.
- Excellent interpersonal skills, especially regarding:
- Teamwork and collaboration
- Client focus
- Verbal and written communication
- Strategic thinking
- Results driven
- Change and innovation
- Strong knowledge of Manufacturing Execution Systems (MES) specifically Emerson Syncade.
- Knowledge of industry standard integration protocols and programming applications such as OPC, BACNet, ODBC and Web API.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics, Cell Therapy and clinical manufacturing.
- Ability to create and document Technical Architecture for computerized Manufacturing systems.
- Strong technical and problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Familiarity with Business Intelligence (BI) and reporting programs including InfoBatch or similar tools.
- Understanding of computer system validation.
Education and Experience:
- Bachelor’s degree in an engineering or MIS discipline (advanced degree is preferred)
- Must have experience with Tier-1 MES, preferably Emerson Syncade, in a bio-tech manufacturing environment.
- Must have experience implementing, maintaining and/or interfacing with Data Historians (OSIsoft PI system) and relational databases (SQL).
- Must have experience implementing, maintaining and/or interfacing with Control Systems, preferably Emerson DeltaV.
- Must have at least 10 years of hands-on experience in a biotech manufacturing and supply chain environment
- Hands-on experience in designing, building and supporting interfaces between ERP, Quality, MES, Engineering and shop-floor boundary systems.
- Solid knowledge of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
- Strong working knowledge and accountability of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
- Sound understanding of Electronic Batch Records (EBR) and Review by Exceptions (RBE).
- Must have prior experience working on a project team to implement, customize, or enhance an MES system.
- Experience with business process re-engineering, including documenting workflows and developing functional specifications.
DUTIES AND RESPONSIBILITIES:
- Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the MES, DCS and Historian systems.
- Collaborate with business process leads to design master data, recipes, etc.
- Accountable for operationalizing the manufacturing and peripheral systems.
- Act as a site lead for the support of manufacturing systems.
- Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR T manufacturing.
- Assist the leadership team with establishing a support organization and Service Level Agreements (SLAs).
- Manage daily operation and future enhancements of MES and lower level systems as an IT system owner and technical expert.
- Participate in global harmonization of MES implementations, equipment/process and instrument interfaces.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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