Position: Drug Substance Development Leader
Location: Flemish Region, Belgium - Mechelen ideally
Client: Global Leading Biotech
FTE: Contract - 50% - 60% FTE - 7 months
Planet Pharma are partnered with a global leading Biotechnology company, based in the Flemish Region of Belgium, who are currently looking for a part-time (50-60% FTE) Drug Substance Development Leader, for a 7 months contract initially.
Main Responsibilities:
* Lead and manage drug substance (DS) development and manufacturing for a late-phase small molecule project.
* Develop and execute DS strategy aligned with the overall CMC development plan, covering both non-GMP and GMP activities.
* Oversee manufacturing activities including process scale-up and production of non-GMP and GMP batches.
* Manage and coordinate external service providers (ESPs) for all DS-related activities.
* Identify and synthesize impurities, including mutagenic impurities, in collaboration with safety and analytical teams.
* Review and interpret analytical and process development data; implement necessary process optimizations.
* Monitor and evaluate DS stability data; adjust strategies accordingly.
* Prepare, review, approve, and archive CMC source documents for regulatory submissions.
* Review and approve ESP-provided documents (e.g., protocols, batch records, reports); ensure proper documentation management.
* Ensure ESP compliance with cGMP regulations, in partnership with the Quality and Compliance department.
* Collaborate with internal CMC team members to ensure alignment with project timelines and updates.
Main Requirements:
* PhD in Organic Chemistry
* Strong experience in drug substance development and scale-up
* Small molecule background
* Late-stage development experience
* Analytical understanding
* In-depth knowledge of the drug development process and experience with CROs and cross-functional teams.
* Strong leadership and communication abilities, including experience leading meetings and technical discussions.
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com