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Associate Director or Senior Manager, Cell Therapy Technical Engineer

Employer
Bristol Myers Squibb Company
Location
Seattle, Washington
Start date
Sep 20, 2022

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Discipline
Science/R&D, Biotherapeutics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work
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Job Details

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.

Job Summary

BMS is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

BMS is growing and we are looking for a Senior Process Engineer to join our team in Global MSAT. The successful candidate will lead efforts related to tech transfer and lifecycle management thereafter. The Senior Engineer will be responsible for leading cross-departmental groups, and planning/executing risk assessments and strategy development for analytical comparability exercises to enable change implementation. This role is responsible in developing study design and statistically derived criteria to evaluate pre-change and post-change results and summarize the strategy in technical protocols and results in technical reports. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Sr. Process Engineer will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products.

Primary Responsibilities

  • Collaborate with process engineers and analytical scientists and guide comparability design by applying in-depth CAR-T and viral vector manufacturing process knowledge
  • Perform statistical analysis of product attribute data as well as statistical tests and evaluation to assist the design and execution of comparability exercises for cell therapy and vector products
  • Lead execution of process risk assessments, development of criteria justifications, and development of comparability protocols
  • Author regulatory filings summarizing the strategy and results from comparability exercises
  • Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality
  • Lead efforts focusing on alignment and harmonization of comparability strategies across multiple sites
  • Leverage and maintain strong relationships across multiple sites
  • Coach/support junior staff on the team on complex technical issues

Required Qualifications

  • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment
  • Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment
  • Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes
  • Experience with cGMP, ICH guidelines, control strategy development, and working within a Quality organization
  • Excellent problem solving skills
  • Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)
  • Able to creatively manage time and elevate relevant issues to project lead and line management
  • Strong scientific and excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
  • Detail oriented with excellent verbal and written communication skills

Preferred Qualifications

  • Preference given to candidates with experience writing regulatory submissions
  • Knowledge of cellular immunology and cell therapy experience a plus

education requirements

  • MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 8 – 10 years relevant technical experience in technical development, manufacturing science or other disciplines in technical operations

BMSCART

#LI-Hybrid

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.

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