Associate Director Cell Therapy Engineering and Support

Profile

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 Manufacturing Science and Technology (MSAT) Cell Therapy Engineering and Support team at the Juno Manufacturing Plant's (JuMP) in Bothell, WA is responsible for maintaining the site's Right to Operate, enabling excellence in manufacturing by providing technical support to the production organizations while driving continuous production improvements, and collaborates with site and global partners to transfer, implement, file, and license new products/processes while maintaining existing products/processes. The Associate Director, MSAT Cell Therapy Engineering and Support manages a team of process engineers responsible for monitoring, troubleshooting, and improving cell therapy unit operations, provides strategic and technical leadership both within and outside of the site, establishes s ite-specific support and technical transfer best practices, a nd assures on-time completion o f his/her team's deliverables. This position reports to the Director, MSAT.

DUTIES AND RESPONSIBILITIES:


Lead team of process engineers with varying levels of experience from entry level to senior/principal engineer
Effectively manage Cell Therapy Engineering and Support team in the following areas:
Immediate resolution of emergent production issues including troubleshooting on a 24/7 basis
Support for deviations and investigations
Identification and implementation of immediate corrective or preventative actions to ensure continued compliant operation
Support and/or lead identification and implementation of near- and long-term changes including root cause analysis, and ownership/sponsorship of CAPAs
Support and/or lead a change controls related to product/process improvements and product lifecycle
Establish Frontline Support and site-specific CMC/technical transfer best practices, strategies, and maintenance/management of these processes
Establish and implement site process monitoring/continuous process verification strategy to ensure processes are performing as expected
Identify, 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.
Promote problem identification and the creation of meaningful solutions through a culture of proactive problem prevention
Partner with global and site functions to define, conduct risk assessments, transfer, file and license new products/processes at the site
Engage in strategic and purposeful discussions to ensure stakeholder alignment when executing CMC lifecycle activities
Partner with Quality Assurance in maintaining high compliance standards
Interpret and relate Quality standards for implementation and review
Provide input to revised and new site-specific as well as global policies and procedures
Influence and review technical content within the CMC sections of regulatory filings
Maintain the team's constant state of inspection readiness
Function as a primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
Serve as MSAT representative on cross-functional and multi-site teams
Build and maintain effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs
Be an active and visible change agent, promoting flexible and open mindsets to new opportunities. Exercise sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives
Based on department, site, and organization goals, establish, monitor, and drive to completion MSAT Cell Therapy Engineering and Support team's annual goals
Effectively motivate and mentor team members thereby enabling their career growth
Retain and develop key talent through timely performance discussions, annual performance evaluations, and individual career development plans
Establish and track team's performance metrics, provide progress reports to stakeholders


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:


BS/MS in Engineering or Biotechnology related field


Experience

Basic Qualifications:


12 years relevant experience in cGMP environment for Biologics/CMC/Vaccines
5 years managing direct reports with varying levels of experience
Thorough understanding of Good Manufacturing Practices as they apply to bioprocess manufacturing
Knowledge ICH guidelines Q5E, Q7, Q8, Q9, Q10, Q11, Q12, and Q13

Experience leading a high performing team driving an environment of collaboration, timely and effective communications, a sense of urgency in order to achieve immediate and future goals

Experience representing technical operations during internal as well as US- and international-specific health authority audits, particularly pre-licensure inspections (PLIs)

Excellent organizational skills and the ability to make sound decisions when allocating resources and managing team's priorities
Ability to communicate clearly and professionally both in writing and verbally


Preferred Qualifications:


Experience with cell therapies highly desired


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.

Company: Bristol-Myers Squibb

Req Number: R1526685_EN

Updated: 2020-06-30 00:00:00.000 UTC

Location: Bothell,Washington

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.

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