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Associate Director, Network Materials QC

Employer
Bristol Myers Squibb Company
Location
Seattle, Washington
Start date
Dec 1, 2023

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

This leadership role will lead a global QC team responsible for technical program and method oversight for Raw Materials (RMs) and QC Critical Reagents (QCCRs) within the Network Cell Therapy commercial and late-stage development. The scope of this role includes media, buffers, reagents used in drug product manufacturing as well as materials used in QC requiring testing prior to use (QCCRs) and custom QC critical reagent suppliers. This role is above site (Network QC) and supports all Cell Therapy commercial manufacturing sites.

Shift Available:

  • Monday - Friday Onsite Day Shift

Responsibilities:

  • Leadership of the team responsible for management of the Network Material QC program inclusive of raw materials and QC critical reagent testing methods, technical QC support for these materials as well as strategic direction of the Material QC program shared across the Cell Therapy network of commercial sites. Further, lead the functional QC support for the suppliers, contract testing labs, troubleshooting/ investigations, material qualifications, onboarding and changes associated with Network Materials.

  • Provide oversite of the materials QC program for the network of sites.

  • Set strategic direction for the implementation of risk minimizing sourcing and testing strategies for QC critical reagents used in Drug product and vector testing.

  • Set strategic direction for the implementation of risk minimizing testing strategies for raw materials used in drug product and vector manufacturing.

  • Oversee implementation, review and approval of documents to drive and support the material Network QC program including incoming materials specifications, Justification of Specifications and material qualifications.

  • Coordinate and work collaboratively with cross-functional teams including MS&T, AS&T, supply chain, Procurement and across multiple commercial manufacturing sites to drive the materials QC program.

  • Measure and maintain KPIs and Quality metrics.

  • Provide expert level industry bioanalytical knowledge and in-depth understanding of bioanalytical techniques and quality control strategies.

  • Lead the handling complex issues, provide troubleshooting, investigations and Inspection support.

  • Responsible for management of group projects; designs and execution of experiments, result analysis, technical reports and continuous improvement projects.

  • Perform analyses and determine appropriate actions with regards to lab investigations, deviations, CAPAs, and continuous improvement to ensure continued compliance with all cGMP requirements.

  • Anticipate and troubleshoot issues with regards to processes, procedures, documentation, instrumentation and electronic systems.

  • Lead and develop best practices within the team including fostering lean principles.

  • Mentor and coach group members for ongoing growth with technical expertise and skills, soft skills and leadership.

  • Develop and sustain self-directed work teams to support team ownership for effectively and efficiently completing activities.

  • Participate in hiring processes internal and external to the group.

  • Determine group training curricula and oversee development of training content.

  • Provide feedback to direct reports through regular coaching sessions.

  • Utilize company-guided performance management tools and processes.

  • Ensure group members have and use appropriate engineering controls, safety procedures and PPE.

  • Encourage a strong culture of team and individual safety awareness and accountability.

Knowledge & Skills:

  • Self-directed with a high degree of professional integrity, highly organized and detail oriented. Ability to work independently and to collaborate cross functionally to drive operational and quality excellence.

  • Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.

  • Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences including ability to interpret and author general, technical, and complex business documents.

  • Advanced understanding of pharmaceutical regulatory requirements and guidelines as related to the manufacture of cell therapy products.

  • Advanced understanding of technical purpose and capability of laboratory instrumentation, software and techniques.

  • Intermediate proficiency in Microsoft Word, Outlook, and Excel as well as project management.

  • Ability to effectively collaborate cross-functionally and across multiple sites.

  • Demonstrated critical reasoning, strategic thinking, problem solving, troubleshooting, investigation, and decision-making skills.

  • Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.

  • Advanced knowledge and implementation of Quality Management inclusive of SOPs, Change Controls, Deviations, CAPAs, Risk Assessments and data integrity principles.

  • Strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.

Basic Requirements:

  • PhD in Biological Science, Biomedical Engineering, Chemical Engineering, or related discipline with 4 years development / Quality Control, AS&T or Quality experience; or MS with 6+ years development / Quality Control, AS&T or Quality; or BS with 8+ development / Quality Control, AS&T or Quality experience in Cell Therapy, biologics, or vaccines. A combination of related experiences/degrees may also be acceptable.

  • 5+ years hands-on bioanalytical testing techniques.

  • 5+ years people leadership experience.

  • 2+ years material experience required.

Preferred Requirements:

  • 2+ years of commercial manufacturing experience.

  • 3-5 years of Quality experience.

The starting compensation for this job is a range from $149,000 $188,000, plus incentive cash and stock opportunities (based on eligibility). Salaries may vary if located outside of Washington State. The starting pay rate takes into account characteristics of the job, such as required skills and the geographic location where work is performed. Final, individual compensation is decided commensurate with demonstrated experience. For more on benefits, please visit our BMS Careers Site. Eligibility for specific benefits listed therein may vary based on job and location.

BMSCART, #LI-Onsite

If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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