Date: as soon as possible – full-time

Your responsibilities:

  • Drive the characterization, selection and development of the best primary packaging combinations for Formycon’s biosimilar programs
  • Manage development, characterization, sourcing of primary and secondary packaging components with internal and external partners (e.g. suppliers, CROs)
  • Prepare and/or review all documentation related to primary and secondary packaging components (e.g. customers specifications, control procedures, an-alytical methods protocols and reports)
  • Take the lead for the qualification and maintenance of equipment for primary packaging and device testing
  • Plan and drive secondary packaging and outer sterilization together with external partners
  • Setup, support/maintain the design history file (including all related activities and documentation) for combination products together with internal and external experts
  • Comply with the requirements of the Quality Management System (QMS) of Formycon AG
  • Compile high quality scientific documents as needed (e.g. technical documentation package, SOPs, reports, risk assessments, master plans, sampling plans, memos) to hand over to internal and/or external partners (e.g. Quality, regCMC, health authorities, external companies) and support generation of international registration documents (CTD, BB, IMPD, IND etc.)
  • Represent Packaging and Device Development for the Drug Product Area in internal and external meetings and conferences
  • Establish and coordinate relationships with internal and external partners (CDMOs, CROs, license partners)
  • Lookout for new packaging, devices and related technologies to be introduced in upcoming programs

Your qualifications:

  • Degree (master or diploma) in Life Science, Pharmaceutical Sciences or a comparable field
  • A minimum of 3 years’ experience in the biopharmaceutical industry or a highly related field
  • Knowledge in biosimilars or biologics of advantage
  • Experience in the management of external partners
  • Good presentation skills
  • Very good team player, result oriented, well organized, proactive, problem solver and able to work independently
  • Creativity and enthusiasm for working in a dynamic fast growing biopharmaceutical company
  • Fluent in written and spoken English required, German knowledge is desirable
  • Proficient in MS-Office
  • Work permit for Germany is mandatory

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.