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Associate Director, Process Equipment Engineering (m/f)

Workscope: Project Management

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Juno Therapeutics GmbH is an innovative German subsidiary of a fast-growing American biotechnology company in the field of adaptive cell therapy (www.junotherapeutics.com). Our goal is to develop new immunotherapies for the treatment of tumors. For our Site in munich, we are looking for an

 
Associate Director, Process Equipment Engineering


Job Summary
 
The primary focus of the Associate Director, Process Equipment Engineering is to lead a team focused on the design, fabrication, qualification and implementation of custom process equipment to enable best-in-class manufacturing methods for T cell therapies. The Associate Director will provide strategic and technical oversight for development of process equipment to enable novel cell separation strategies. This candidate will interface and actively partner with internal project teams, external collaborators, scientific co-founders and third party system integrators on topics related to development of process equipment.



Primary Responsibilities
  • Build and lead highly successful team of scientists and engineers.
  • Facilitate transition of proof of concept equipment to GMP-ready state.
  • Define appropriate equipment functional specifications with Juno technology development team; enable and track progress against specifications.
  • Manage vendor relationship to ensure new equipment delivery is performed on schedule and to budget.
  • Review, update, and/or generate of GMP lifecycle documentation (URS, FS, DS, etc.) and corresponding control software.
  • Facilitate Factory Acceptance Testing and Site Acceptance Testing on new process equipment.
  • Develop equipment automation that can interface with site automation to ensure proper operation and data historization.
  • Develop and maintain strong business relationships across the company, including with process development, manufacturing and regulatory teams.
Required Qualifications
  • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
  • Experience navigating regulatory authorization process for new equipment or raw materials utilized in GMP manufacturing.
  • Experience integrating systems (hardware, software, automation, disposables) and delivering custom process systems.
  • Experience in a pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
  • Experience with developing GAMP controls documentation as well as reviewing/approving vendor supplied documentation (URS, FS, SDS, and Software Test Plans).
  • Strong organization, interpersonal, oral and written communication skills in German and English.

Preferred Qualifications
  • Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
  • 5+ years combined experience with Emerson Delta-V DCS systems version 11 or above.
  • Excellent control systems automation background focused specifically in design, installation, programming and validation of automated processes.
  • Knowledge of ASTM 2500, S88 and S95 techniques. Batch processing experience.
  • Strong leadership, technical writing, and communication/presentation skills.
Education Requirements

MS or Ph.D in Chemical Engineering, Electrical Engineering, or Mechanical Engineering with 5+ years of commercial biopharmaceutical process development experience.



We are looking forward to receiving your meaningful application! Please send your cover letter, CV, certificates, and letters of reference to:


Juno Therapeutics GmbH
Gabi Gast
Grillparzerstrasse 10
81675 München

email: gabi.gast@junotherapeutics.com
 

Contact detail


How to apply:
We are looking forward to receiving your meaningful application via email!
Send application to
Please send your cover letter, CV, certificates, and letters of reference to:

Juno Therapeutics GmbH
Gabi Gast
Grillparzerstrasse 10
81675 München

email: gabi.gast@junotherapeutics.com

Job profile


Working hours
Full-Time
Contract duration
Permanent
Type of job
Specialist
Work experience
jobexperience is required
Region
Germany (Bayern)
Working place
81675 München
Area of expertise
Biology & Life Sciences, Pharmaceutics, Biotechnology
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