Affivant Sciences: Head of CMC (f/m/d)

Location: Roivant Sciences GmbH, Viaduktstrasse 8, 4051, Basel, Switzerland

Affivant Sciences is an incubating private biotech company within the Roivant Sciences company portfolio. An immuno-oncology company focused on the development and commercialization of novel bispecific innate cell engagers for multiple cancer targets through its strategic collaboration agreement with Affimed in Germany.               

Affivant owns global rights to the lead program AFM32 as part of this Roivant-Affimed partnerhip announced in Nov 2020. Moreover, Affivant has opt-in rights to 2 addtional exclusive Affimed pipeline compounds. Affivant is fully owned and funded by Roivant Sciences, headquartered in Basel, Switzerland with offices in Boston and New York City, US.

For our headquarter office in Basel, we are looking for an Head of CMC. 

The Head of CMC will lead the selection and management of external CDMO’s involved in manufacture and analysis of Affivant’s bispecific antibodies. S/he will lead process development and optimization activities to ensure a robust, scalable, and cost-effective manufacturing process for drug substance and drug product. The Head of CMC will plan and lead activities for clinical manufacture and eventually for BLA file and launch (including planning for process characterization and validation). S/he will ensure manufacturing and analysis are performed in accordance with cGMP and FDA/EMA regulations.Furthermore, the Head of CMC will be responsible for developing CMC regulatory strategy and authoring quality modules for regulatory files and represent CMC in interactions with regulatory agencies. The Head of CMC will manage the supply chain for Affivant projects and lead packaging and labelling activities for clinical trial supply. The Head of CMC / CTO will supervise and develop direct reports on the CMC team.

The successful candidate will be an experienced drug development scientist with a background as a Chemistry, Manufacturing and Controls expert in the biotechnology and/or pharmaceutical industry. The successful candidate will likely have a mix of the following experience / education:

  • Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field.
  • 15+ years experience, in biologics drug development and manufacture
  • Proven expertise and track-record of leadership of process and analytical development of biologics. Experience in setting CMC strategy, supply planning and budgeting.
  • Must have demonstrated leadership experience in managing diverse project activities (upstream, downstream, drug product/formulation, analytical, clinical supply) with contract CDMO facilities.
  • Track record of authoring CMC sections of successful IND, CTA, NDA, and/or BLA submissions
  • Knowledge of cGMP regulations, ICH guidelines, and the CMC content of global regulatory submissions
  • Strong communicator
  • Willingness to travel within EU and US
  • Strong interpersonal skills including presentation capabilities and the ability to work effectively with his/her peers, direct reports, other functional leads at all levels, and the Company Board.
  • Drug Development Experience:
    • Substantial biotech/industry drug development experience is necessary, a track record leading process development and product supply activities for biologics.
    • Demonstrated success in leading CMC programs at all phases of development and proven trackrecord of developing robust manufacturing processes and managing clinical manufacture at external CDMOs

 

Please note: As we are exclusively recruiting with Coulter Partner, please send your application documents directly to AffivantCV@coulterpartners.com. Affivant will NOT accept any applications.

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