Senior Process Engineer Cell Therapy Manufacturing Science amp Technology

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.

Division

Cell Therapy Development and Operations: Manufacturing, Science and Technology (MSAT)

Position Summary

Come and join the Bristol Myers Squibb Cell Therapy Development and Operations (CTDO) Division and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Global Manufacturing Science and Technology (GMSAT) Division of CDTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network. We are looking for a Senior Process Engineer to join our team in Global MSAT.

Direct Reports

N/A

Detailed Position Responsibilities


Lead process and technology transfers, change management, and technical process support for cell therapy and vector products
Lead development of process control strategies including execution of process risk assessments, development of range justifications, and development of continued process verification strategy
Author regulatory filings across product lifecycle
Perform and support data monitoring of manufacturing processes to understand process capability, troubleshoot investigation-driven events
Develop, understand, and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within manufacturing Juno unit operations
Support design activities for clinical and/or commercial facilities
Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites
Leverage and maintain strong relationships with external partners
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
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, PPQ (process validation), control strategy development, and working within a Quality organization
Experience working in a self-driven, performance/results oriented, fast paced matrix environment
Excellent problem-solving skills
Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
Able to creatively manage time and elevate relevant issues to project lead and line management
Strong scientific and technical writing
Detail oriented with excellent verbal and written communication skills


PREFERRED QUALIFICATIONS:


Preference given to candidates with experience writing regulatory submissions
Knowledge of cellular immunology a plus
Experience with Disposable technologies such as SUBs and SUMs
Experience with cell culture processes
Experience managing CMO relations


EDUCATION REQUIREMENTS


PhD or MS / BS in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 7 years relevant experience in biologic process development or commercial biologic manufacturing process support


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: R1527801_EN

Updated: 2020-07-21 00:00:00.000 UTC

Location: Seattle,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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