JOB DESCRIPTION

Position 
Job title: CMC Manager
Department: CMC
Location: Berlin (Germany)
 

Company

PentixaPharm GmbH is part of the Eckert & Ziegler Group, one of the world's largest manufacturers of radioactive components for medical, scientific and metrological purposes. The group focuses on applications in cancer therapy, industrial radiometry and nuclear medicine diagnostics.

PentixaPharm's operations are divided into the clinical development and chemical manufacturing of PentixaFor and PentixaTher, an innovative pair of theranostics that specifically target the CXCR4 receptor found in most rapidly progressing diseases, including hematologic and solid cancers and cardiovascular malignancies. PentixaPharm employs 15 people at its sites in Berlin and Würzburg.

Purpose of the Position

  • Lead development programs and report to the managing director, department CMC, management of outsourced and internal project activities. Timely secure high quality of suppliers and internal deliverables, including appropriate technical, quality and regulatory documentation.
  • Support clinical trial supply of therapeutic and diagnostic radiopharmaceuticals by managing clinical study centers and monitoring of radiopharmacies.
  • Ensure conception, delivery and communication of technical activities as part of development project portfolio to keep high level of competitiveness. Ensure the accuracy and reliability of the data generated and provide the adequate scientific interpretation.
  • Implement the up to date internal and external regulatory guidance and process; deliver milestones within time, resources and cost agreed by the company.

Main Responsibilities and Tasks

  • Lead  Radiopharmaceutical Development projects and management of drug product manufacturing activities
  • Management of contract manufacturing partners and suppliers
  • Writing of regulatory documents and submission of relevant CMC documents for clinical trial applications
  • Ensure a high quality of supplier deliverables for clinical studies and market supply on time
  • Budget control of above activities 
  • Report to managing director CMC and boards
  • Expand internal quality assurance system
  • Set-up of radiotracer production methodology
  • Support set-up of new radioactivity lab facilities
  • Liaise with intercompany organisations to support CMC development process
  • Liaise with intercompany organisations to support pre-clinical and clinical development

Experience / Qualifications

Ideal: Qualification/degree and significant Industry experience in radiopharmaceutical    development, handling of radioactive substances

  • Degree in Chemistry, Pharmacy or PhD in Pharmaceutical Sciences with significant experience in injectable product area

Minimum: Experience in handling of radioactive substances

  • Ph.D. in Chemistry or Pharmaceutical Sciences

Languages: Fluent English and German

Required Competencies

  • Strong awareness of GMP-standards
  • Experience in development and production of (radio)pharmaceuticals preferable
  • Experience in handling radioactive substances
  • Analytical Chemistry (HPLC, UPLC, TLC) and injectable formulation development
  • Leadership / Willingness to lead, take charge, and offer opinions and recommendations especially with regards to working in multidisciplinary teams in a complex global environment
  • Strong ability to network in the area of radiolabelled injectable formulation to identify potential partners and new methodologies
  • Innovation / being proactive, creative and demonstrating alternative thinking to develop new ideas and solve problems quickly

Other Useful Information

  • Family-friendly orientation with flexible working hours
  • Performance-related compensation
  • Opportunities for further qualification
  • Pleasant working atmosphere in a committed team
  • Flat hierarchies and short decision-making processes
  • Parking facilities and good public transport connections
  • Various internal and external catering options
  • Attractive working environment at the health location Berlin-Buch (www.berlin-buch.com)
  • Wide range of health and sports activities (e.g. company doctor, www.campusvital.de)

If you want to become a part of our young and motivated team and if you are ready for a new challenge, we are looking forward to your complete application - please send it to: anne.lobach@pentixapharm.com.

We are looking forward to receiving your application!

www.pentixapharm.com

OFFICE
PentixaPharm GmbH

Headquarter
Bismarckstraße 13
97080 Würzburg
Germany
Fon +49 931 991360-76

Robert-Rössle-Str. 10
13125 Berlin
Germany
Fon +49 30 9489-3220