Senior Process Engineer

Celgene   •  

Seattle, WA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 27 days ago

1900788

Juno Therapeutics, a Celgene company, is a clinical-stage company 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.

Juno 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 transfer of manufacturing technologies from process development and responsibilities of lifecycle management thereafter. The Senior Engineer will be responsible for the transfer of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), training of personnel, change control ownership, and other quality system related deliverables. This person may be responsible for and support processes from early clinical phase through development of PPQ strategies and commercial manufacturing support. 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

  • 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 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


Education requirements

  • MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 7+ years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support