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Bristol Myers Squibb: Senior Director Or Executive Director, Analytical Development – Cell Therapy

Bristol Myers Squibb

This is a Full-time position in Lowman Beach Park, WA posted October 13, 2021.

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today.

With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

The Cell Therapy Technical Development organization is looking for an exceptional leader to develop and implement innovative analytical technologies and testing strategies from IND through commercialization and Life Cycle Management.

This is a large department consisting of more than seventy full time employees and additional contracting work force that are spread between Seattle WA and Warren NJ.

This leader is responsible for driving analytical technology innovation and the development strategies for vector, gene editing tools and CAR-T drug products, along with fostering a culture of inclusion, empowerment, scientific excellence, collaboration, and engagement.

He/she will create a comprehensive roadmap for product analytics, contribute long-term technology and operational strategies for the clinical and commercial QC network, drive rapid implementation of new technologies into CMC programs, ensure functional excellence for regulatory strategies for future INDs and BLAs, and ensure operational efficiencies leveraging automation and state-of-the art-data management.

This is a significant, global leadership position with critical accountabilities and influence on the product portfolio from pre-candidate nomination through commercialization and beyond.

This is a significant leadership position that requires strong technical partnership and collaboration with multiple stakeholders including Product Sciences, CMC Biostatistics, Process Development, Quality, Regulatory, Research and Early Development.

This role can be based in Seattle, WA or Warren, NJ.

The incumbent has the following technical and leadership responsibilities:TechnicalDemonstrate technical leadership and business acumen while collaborating closely with leaders from other tech dev departments, Quality, REGCMC, R& ED, Business Strategy, Finance, and potential external partners.Serve as a thought leader for analytical technology innovation, integrated process and analytical control strategies, and integrated technical development and regulatory strategies for cellular drug products.Create a comprehensive roadmap for Cellular Drug Product analytics, vector and gene editing critical raw materials, process, and product residuals.Drive rapid implementation of new analytical technologies into CMC programs, ensure functional excellence for regulatory strategies for INDs and BLAs, and ensure operational efficiencies leveraging automation as well as state-of-the art-data analysis and management.Direct and scale analytical development strategies including technologies, clinical and commercial specifications for engineered Cell Therapy products.Provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development and manufacturing.Ensure scientific integrity and quality of regulatory submissions and support interactions with the global health authorities.Contribute to CTDO Strategy including integrated product development strategies, risks identification and mitigation plans, and program development activities, timeline, and resource allocation.

LeadershipBuild and strengthen a cohesive and motivated department that understand its issues, challenges and opportunities.Engage and retain talents by understanding individuals’ development needs, connecting with business requirements, and explaining the what, the why, and the how.Retain and recruit the best and brightest leaders, scientists, engineers, and analysts.As part of Tech Dev LT, drive technical vision, strategy and product development roadmaps to meet corporate business requirements.As part of Tech Dev LT, help define and effectively communicate a compelling scientific vision internally and externally.As part of Tech Dev LT, contribute to cell and gene therapy insights and technology through publications and external partnership to deliver best in class therapies to patients.

Education and Experience RequiredMS/Ph.D.

degree in Immunology, Life Sciences, Chemistry, Pharmacy or Engineering or similar > 15 years (>20 years for Executive Director) of experiences in the development and approval of cell & gene therapy products or biologics.Knowledge and direct experience in developing analytical technology and methods, characterization and release of Cellular Drug Products are strongly desired.

Pivotal and approval experience are preferred.Experience with regulatory filings of immunotherapy products is preferred.Demonstrated excellence in developing, mentoring, and managing staff.Proven leadership and ability to positively influence colleagues and key decision makers.Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.Demonstrated business acumen with the ability to draw insights from data quickly, perform analysis, and present business cases.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team.

Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science.

From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine.

Join us today.

BMSCART 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 adastaffingsupport@bms.com.

Visit careers.Bms.Com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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