We are looking for a Drug Substance Manager who will manage and monitor R&D activities within the Chemistry Manufacturing and Controls (CMC) area, focused on active pharmaceutical ingredients (API) such as but not limited to the following: chemical development, manufacturing, product release, control of stocks and deliveries, control of data generated as per current guidelines (cGMP, ICH) and regulations (EMA, USA FDA).
Key Responsibilities
What will you do?
Vendor Selection And Project Follow-up
Collaborate in the preparation of requests for proposals (RFP) for the projects;
Assist in the selection of the appropriate CRO/CDMO vendor;
Monitor vendor activities and organise follow-up meetings on regular basis.
Drug Substance And Process Development
Define the API development and manufacturing strategy in alignment with Global project/CMC plans;
Review the scope of work and results from R&D chemical development activities of APIs, radiolabelled compounds, impurities or related metabolites;
Support in the preparation and follow-up of CMC project plans and timelines based on Global project plans, with special focus on planned pre-clinical and clinical studies, regulatory submissions and future industrialisation objectives;
Review and when necessary approve development records, master manufacturing batch records, manufacturing protocols and the corresponding reports and product specifications.
GLP/GMP Manufacturing Of API Batches
Assist experts of other development areas in the company (e.g. pre-clinical, clinical, project management) to estimate the required API quantities and required quality to fulfil the Global Project Plans. Propose appropriate batch size and stocks necessary;
Monitor the progress of manufacturing activities;
Assure activities are performed according to GMP, SOPs and applicable regulations
Review executed records and CoA/CoC for compliance before batch release.
Regulatory Support
Organize and compile all the CMC Drug Substance specific supporting data in shared folders;
Author or collaborate to the CMC Drug Substance sections in regulatory submission documents such as IND, IMPD, IB.
Additional Responsibilities
Assist Head of Departments and Project Managers in the overall plan and budgeting process, by contributing with the CMC/API inputs.
Skills, Knowledge And Expertise
Organic Chemist (Master degree or PhD) or equivalent qualification with 10 years' pharmaceutical industry experience;
Hands-on experience on scale-up processes and industrialisation of APIs;
Knowledge of the technical concepts and interpretation of results for the following analytical chemistry techniques: NMR, IR, UV, HPLC, GC, LC/MS, PSD, XRD, and DSC;
Regulatory and project management experience;
Knowledge of development of pharmaceutical products;
Writing skills focused on technical and regulatory documents.
Knowledge of and experience in cGMP requirements and international regulations (ICH, EMA; US FDA), and applicable regulatory and QA CMC documents.
Understand protocols, SOPs, and technical knowledge of the manufacturing and testing of the drug substance.
Benefits
The opportunity to develop pioneering science in a young biotech company
Challenging and innovative work environment as part of a driven team
Flexibility and responsibility based in Antwerp with remote working options that can be tailored for you
Competitive salary and benefits
An agile and fast paced environment
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Biotechnology Research
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