Head of CMC
During the coming years, we will take our Her2-directed antibody-drug conjugate LxC-001 to the clinic. To coordinate our outsourced manufacturing processes, and to attain our product at the highest quality level, we are searching for a Head of Chemistry, Manufacturing and Control.July 25, 2019
For the manufacturing of clinical-grade product, LinXis follows the outsourced manufacturing model. Despite the simplicity of our manufacturing process, ADC manufacturing chains are inherently complex as they entail antibody production, drug synthesis, and actual antibody-drug conjugation. As Head of CMC, your main objective will be to steer and align all external manufacturing partners, in order to ensure product availability along all development stages. On a daily basis you will:
- Support transfer of LinXis technology to the external manufacturing partners.
- Oversee process- and analytical development activities towards GMP production.
- Ensure alignment of individual manufacturing partners across the entire manufacturing (supply-) chain, also with regards to product quality (GMP).
- Ensure timely availability of the actual products across the various stages of development (development - tox - clinical).
- Deliver quality content of phase I/II regulatory filings, i.e. IND/IMPD eCTD module 3.
To qualify for this position, we expect you to have:
- An education in the field of medical (bio-) technology and life sciences. We expect PhD operating level – but experience is a must, and can compensate for education.
- A background (>5 years) in an industrial environment, with experience in process- and/or analytical development, qualification, and -validation.
- Experience in the writing of regulatory documentation (IND/IMPD).
- Good understanding of the principles of GMP.
- Experience in operating in cross-functional teams – connecting CMC with research, non-clinical development and clinical development.
- Knowledge of regulatory policies and guidelines - ICH, Ph. Eur, USP, EMA, FDA, best industry practice.
What we offer:
We offer a unique career opportunity under attractive conditions. The small size and early stage of LinXis guarantees a dynamic and challenging work environment, and provides substantial possibility for personal growth. Flexibility and a hands-on mentality will be your most valuable assets. If you are up to the challenge of helping us make the difference, please send your resume and letter of motivation to firstname.lastname@example.org. You will be based in our Amsterdam office location.