About the Job
Leads and manages all Drug Product project activities linked to the development of radiopharmaceutical parenteral, both ready to use and freeze-dried products.
* Designs, plans, performs, interprets, and reports the results of scientific experiments for the preparation and timely delivery of drug product.
* Supports & coaches team members, participates in scientific teams and contributes to the overall Technical Research and Development (TRD) strategies and goals.
Responsibilities:
1. Leads and manages all formulation and process development activities for assigned projects.
2. Develops sound Drug Product project strategy including contingency planning and risk assessments in line with the overall TRD project plan, development guidelines, SOPs and TRD/RLT strategy.
3. Represents DP project teams in TRD sub-team, with strong sense of accountability and responsibility.
4. Ensures adherence to the EP/LP project review process through relevant governance boards.
Requirements
We are looking for a highly skilled professional with:
* PhD in Pharmaceutics or related sciences with a minimum of 6 years of proven experience within the pharmaceutical/biotech industry or a Master's degree with a minimum of 8 years experience.
* Fluent knowledge of English (oral and written).
* Broad and profound understanding of development activities and processes in pharmaceutical sciences.
Key Skills:
* Excellent knowledge of laboratory and/or technical tools (e.g. Quality by Design, statistical software, Process Analytical Technology).
* Strong experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up.
* Solid understanding of relevant GLP, GMP regulations and policies.
Why Us?
We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
A collaborative workplace where everyone feels valued and empowered to make a difference.