Associate Director, CMC

HiFiBiO Therapeutics (Paris, France) Publié il y a 3 jours
About the Position
We are looking for a motivated, proactive, rigorous, and hands-on associate director who will thrive in a fast-paced, dynamic environment. The candidate will join a young and rapidly growing company in the field of antibody drug development and will work closely with the senior management and the project leaders at the Cambridge, Shanghai, and Paris sites. The selected candidate will report to the Global Head of CMC, based in France. The candidate will carry out activities related to the bioprocess development of antibodies and CMC-related regulatory affairs.  The candidate will contribute to the management of the CMC activities carried out by multiple CDMOs, including but not limited to: 
  • Cell line development, MCB manufacture and testing
  • Methods qualification and validation
  • Process development and scale up
  • Pre-formulation and formulation studies
  • Viral clearance studies
  • Generation of material for GLP tox studies and GMP material for clinical studies
  • Fill & finish
  • DS and DP stability studies  
  • Review of the regulatory documentation and IND submission

Job requirement
The successful candidate must have demonstrated, hands-on expertise in the following areas:
  • >5 years’ experience in supervising the activities of CDMOs that carry out the manufacturing development of large molecules, specifically recombinant antibodies
  • Must have knowledge of all key steps required to manufacture antibodies, such as cell line development, method qualification, USP and DSP development, pre-formulation and formulation studies, as well as the manufacture of GMP material
  • >5 years’ experience in authoring and support of the CMC module of dossiers through all phases of the drug development life cycle
  • Experience in leading kick-off, pre-authoring, comment resolution, and other meetings related to eCTD dossier sections for submission
  • Familiarity with country-specific requirements and ability to discuss relevant requirements with the CMC team, as needed
  • Experience in late-stage development of NBE through commercialization is a plus
General skills
  • An exceptionally organized and structured person with proven ability to work independently and take initiatives
  • Accurate, rigorous, and detail-oriented, with a proven, strong capability to review scientific and regulatory CMC documentation in depth 
  • Capacity to handle multiple projects with multiple CDMOs simultaneously and to rapidly and effectively collaborate with project leaders and senior managers located at multiple sites
  • Strong interpersonal and teamwork skills, including the ability to communicate, collaborate and deliver results in a dynamic, fast paced, highly matrixed environment
  • Strong oral and written skills in English required
  • Positive, flexible and creative mindset
  • Software skills: Microsoft Office package, eCTD

Education/Experience requirements
  • Masters degree or Ph.D. in biochemistry or a related discipline:
  • with strong knowledge and hands-on in CMC development and regulatory aspects
  • with at least 6 years of experience in the industry

Contact

To apply, please send a cover letter briefly stating why you believe you would be a good candidate for the position and your reasons for applying, along with a copy of your CV to:
Nicola Beltraminelli, Global Head CMC, VP


About HiFiBiO Therapeutics:

HiFiBiO Therapeutics is an emerging multinational company mobilizing the human immune system to combat disease and transform patient care. We integrate deep-rooted biological expertise, apply advanced single-cell profiling technologies and leverage open-innovation strategies to accelerate the development of a repertoire of innovative antibody drugs to treat cancer and autoimmune disorders.

Associate Director, CMC

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