Head of CMC
ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.
Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please visit www.asitbiotech.com.
With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):
Head of CMC
As Head of CMC, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies.
You report directly to the CEO and are part of the Executive management.
Your main responsibilities include:
- Lead the overall management of product and process development.
- Manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies.
- Identify, select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP).
- Manage the non-GMP productions and associated analytical development activities.
- Deliver robust, scalable and cost-effective manufacturing routes.
- Implement appropriate analytical methods and protocols in coordination with QA.
- Ensure the compliance of all CMO with relevant regulatory standards.
- Define and execute plans for API and DP validation and registration, in coordination with QA and RA.
- PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Relevant expertise in lab techniques focused on protein expression, isolation and analysis.
- Strong experience in managing CMOs for the manufacture of cGMP APIs and DP.
- Experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings.
- Thorough knowledge of relevant FDA and EMEA regulations.
- Experience with implementing technical, strategic and operational plans.
- Excellent communication and organizational skills.
- Ability to identify and resolve critical issues.
- Fluency in French and English.
- A challenging leading position within a stimulating and dynamic work environment.
- A variety of interesting contacts with international exposure.
- The opportunity to have direct impact on the results of a high-potential biotech company.
- An attractive compensation package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover letter via http://www.pahrtners.be/job/head-of-cmc/ or to email@example.com. Your application and related information will remain strictly confidential.
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