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Biotechnologist, Biochemical Engineer, Biologist as Manager - Production (m/f)

Manager, Production

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 a
Manager, Production
(Full Time, Unlimited)
Tracking Number: 59903

JOB SUMMARY

The primary focus of the Manager, Production will be to manage the new protein manufacturing facility in Munich. The key deliverables for this role are to lead and manage the future manufacturing team of 10-15 employees that will be responsible for the manufacturing of our cell isolation and stimulation reagents for current and future cell therapies according to current GMP requirements. Establish a high performance manufacturing team. Contribute as key project team member to the planning, construction, IOPQ and successful startup of the new manufacturing facility in Munich. Design and generate all necessary documentation (SOP`s, batch records). Guide and train staff with respect to cGMP, upstream and downstream processes. Develop and implement an effective manufacturing scheduling system to maximize manufacturing capacity utilization. Proactively communicate key issues like process deviations and any other critical topics in a timely manner to the appropriate management level. Advise team members and work according to appropriate SOP’s, GMP, OQM, HSE, ISEC and company guidelines. Contribute to IND and BLA filings of the underlying reagents applied for cell stimulation and selection.

PRIMARY RESPONSIBILITIES

  • Lead and manage all practical aspects of the Reagent Manufacturing including planning (personnel, raw materials equipment) execution and documentation of production campaigns.
  • Demonstrate practical experience and expertise in the Manufacturing of therapeutic protein products according to cGMP requirements.
  • As a key project team member contribute to the planning of the new Reagent Manufacturing facility.
  • Optimize unit operations in current platform processes, elaborate strategies to minimize risk for critical components in the supply chain, and evaluate novel technologies and processes for USP and DSP implementation, including automation approaches.
  • Liaise with Process Development, QC and QM teams for smooth execution of pipeline objectives.
  • Work collaboratively with internal colleagues and external partners to transfer manufacturing processes to CMOs and to other internal manufacturing sites as required.
  • Serve as subject matter expert to assist Manufacturing and PD team develop, scale up and implementstate of the art unit operations such as Chromatography systems and Cross flow filtration.

REQUIRED QUALIFICATIONS

  • Proven experience in leading and guiding biopharmaceutical manufacturing teams (people manager), taking responsibility and making risk based decisions.
  • Ability to work in a very dynamic environment with tight timelines, being able to shift priorities as required.
  • Fluent in English and German.
  • Demonstrated and direct experience with cGMP operations and principles.
  • Significant practical experience in Upstream and Downstream Manufacturing of recombinant proteins derived from prokaryotes.
  • Experience in planning, construction and startup of new biopharmaceutical manufacturing plants is an asset.
  • Able to work productively in a highly collaborative, team oriented environment with internal colleagues working to continuously improve manufacturing efficiency and quality.
  • Excellent attention to detail as well as communication and organization skills.
  • Previous experience managing projects in a highly matrixed environment is an asset.
  • Travelling is required for both, domestic and international to an extent of approximately 10 to 20% of the working time.

EDUCATION REQUIREMENTS

  • Ph.D. or Master degree in Biotechnology, Biochemical Engineering, Biology, with at least 8 years of relevant experience in biopharmaceutical Manufacturing.

HOW TO APPLY

Please apply online, quoting the reference number 59903, with your complete application documents as well as your earliest starting date and salary expectations.

We look forward to hearing from you!
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 59903