(Senior) Scientist (gn) Drug Product Process Development

  • Medicine, Pharmacy, Laboratory
  • Fulltime
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Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.
With an experienced team comprised of more than 200 professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

To support our Process Development team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Your responsibilities

  • Develop robust processes for the manufacturing of biosimilar drug product in syringes and vials: design experiments, ensure appropriate execution and documentation for drug product process development and process characterization in agreement with current Quality by Design principles
  • Transfer manufacturing procedures to large-scale GMP facilities, leading process characterization, supporting validation and registration as well as ensuring appropriate documentation and qualifications
  • Be present at Drug Product production sites as needed for transfer meetings and production runs
  • 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 DP Process Development in internal and external meetings and conferences
  • Establish and coordinate relationships with internal and external partners (CDMOs, CROs, license partners)

Your qualifications

  • Master (or equivalent) and preferably 3-4 years of relevant work experience or PhD and at least one year of relevant work experience or other education and relevant work experience
  • Excellent knowledge in drug product development, manufacturing and process transfer
  • Very good team player, result oriented, well organized, proactive, problem solver, able to work independently, strong presentation and communication skills
  • Creativity and enthusiasm for working in a dynamic fast-growing biopharmaceutical company
  • Very good command of spoken and written English. Basic German knowledge is considered advantageous
  • Very proficient in MS-Office package

We offer

  • Flexible working time
  • Hybrid work
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit, great working atmosphere and much more!

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.

Our recruiting process is supported by the recruiter service by Constares GmbH. For initial questions, please contact Rebecca Schön: +49 89 1241 46 204.