Senior Director, Manufacturing Science and Technology (R1556959-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:
This role leads the Manufacturing Science and Technology (MSAT) team of 40+ at the BMS Cell Therapy manufacturing facility in Bothell, WA and will directly report into the Site Head. This role is accountable for the technical support of a multiproduct clinical and commercial GMP autologous CAR-T drug product manufacturing site, including process, facility and equipment validation, manufacturing process support (e.g., investigations, deviations, change controls, CAPAS), automation and MES, plus identifying and implementing policies, procedures and manufacturing strategies to facilitate optimal and compliant production / process and performance.
As a member of the site leadership team, the candidate will be responsible for helping set strategic direction for the site, including leadership of process improvement activity, capacity increases and introduction of the clinical pipeline into the site to deliver on pivotal and commercial launch responsibilities. The ideal candidate will have a track record of talent management, nurturing and driving a culture of collaboration, continuous improvement and alignment between various functions and departments on site and across the network, to ensure that major site & business strategic manufacturing objectives are met. In particular the role requires close partnership with Global MSAT and the broader BMS technical community to transfer, implement, validate, file, and license new products/processes and maintain existing products/processes.
This person is a key leader at the site and has significant responsibility for delivering on critical business expectations, including technical transfer and project milestones and managing a department that will have a direct impact on the growth and success of the BMS cell therapy franchise and its impact on our patients. This role is ideal for a ‘people first’ technical leader, who sees their success through guiding and developing their team to deliver on commitments for the site and broader cell therapy network. Experience in process development, clinical and commercial manufacturing is preferred due to the nature of the BMS cell therapy portfolio and the sites responsibility for pivotal clinal and commercial launch activity.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Bachelor's Degree required (science or engineering). Graduate or higher-level Degree is preferred.
12 or more years' work experience in the pharmaceutical or related industry
8 or more years ' people management experience
- Minimally 15+ years of biotech, cell therapy, pharmaceutical or medical device industry experience in process development, process scale up/manufacturing and process validation.
- Experience with commercial scale manufacturing support for mammalian cell culture, aseptic final product filling/kitting/ labeling, liquid media manufacturing (vials, bags, bottles) and/or analytical reagent (e.g. endotoxin detection assay) manufacture, current Good Manufacturing Practices, US/EU regulations, and supervision.
- In depth knowledge of large scale biologic, pharmaceutical or medical device manufacturing, current Good Manufacturing Practices (cGMP) and US/EU regulations and intermediate knowledge of statistical data analysis.
- Knowledge should include a combination of cell biology, cell culture, and aseptic processing technologies and include small scale (laboratory) experience.
DUTIES AND RESPONSIBILITIES:
Leadership & People Management:
- Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.
- Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
- Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
- As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
- Accountable for overall budget and financial performance of the MSAT organization.
- Proactively promote positive Safety Culture and cGMP operating principles.
- Ensure Right to Operate through compliance with cGMP and regulatory requirements applicable to the department.
Direct areas of responsibility:
- Validation: Own, execute and improve the validation program for equipment, utilities, facility, APS, EMPQ, and ensure compliance with quality system and health authority requirements. Represent Validation program during health authority inspections.
- Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with the quality system and health authority requirements. Represent Automation program during health authority inspections.
- Technical Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes.
- Manufacturing Support: Provide technical support to manufacturing organization including process and product monitoring, compliance to quality systems, and other readiness operational support activities. Respond to and proactively identify issues, determine root cause, and solve forever. Develop, prioritize and drive continuous improvements and other readiness operational maintenance activities that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of production.
WORKING CONDITIONS (US Only):
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.
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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