Senior Formulation Scientist Parenterals and Liquids-1705615960W
Senior Formulation Scientist, P&L, PDMS-DPD, Beerse
Parenterals and Liquids group is a department of Pharmaceutical Development and Manufacturing Sciences - Drug Product Development (PDMS-DPD). The department is responsible for end-to-end drug product development for small molecules including:
* Liquid formulation and process development activities for oral, nasal, and parenteral administrations at early, mid, and late stages
* Formulation and Process transfer activities to GMP pilot and manufacturing plants
* Life cycle management and support of operations at pilot and manufacturing plants
* Development of enabling liquid formulations/processes to enhance patient compliance such as pediatric formulations and long-acting injectable delivery systems
Description of the function
The Senior Formulation Scientist will play a key role and lead the development of liquid formulations and processes for assigned small molecules. The position will require hands-on laboratory work, project responsibility, and oversight of development activities at internal and external parties. The Senior Formulation Scientist will support regulatory submissions of new and existing drugs and involve dossier preparation.
The Senior Formulation Scientist will be accountable in the early phase of formulation/process development of new oral liquid and sterile liquid pharmaceutical products for PDMS focused on formulation screening, formulation optimization, formulation lock, early process development, and process scale-up to intermediate scale for Tox study and clinical Phase 1 /Phase 2a manufacturing.
He/She will work together with the Pharmaceutical Science, Analytical Development, Pilot plant, Scientific Integrator in developing drug products suitable for Tox study and First-In-Human study.
The role requires the development of strong relationships with partner groups in Drug Product Developments, DPD Engineer, Analytical Development, Pharmaceutical Science, and Clinical Supply Chain.
Qualified applicants must have extensive knowledge and experience in liquid and parenteral formulation development especially for poorly soluble compounds, designing suitable processes (e.g. sterile/aseptic, nanonization, lyophilization), and transferring to GMP manufacturing.
A background in formulation/process development of pediatric drug products, long-acting injectable drug products, and lyophilized drug products is beneficial.
The candidate will have a proven track record in writing formulation/process development reports, criticality analysis, batch record, regulatory filing documents, and scientific responses to inquiries from Health Authorities and also will have experience in guiding junior scientists in development activities
The successful candidate should possess excellent interpersonal, scientific leadership, project management, and problem-solving skills and the ability for high performance in a matrix environment.
* A PhD with 3 to 5 years experience or master degree with 9 to 11 years experience in drug product development, pharmaceutical sciences, Industrial Pharmacy or pharmaceutical chemistry, is required.
* Demonstrated competency and experience in formulation and process development in early and late phases within the pharmaceutical industry is required.
* Background in aseptic/sterile process, nanonization, or lyophilization development of injectable solutions and suspensions is required, and knowledge of oral formulation development is desired. Successful work experience in a matrix organization is preferred.
* The candidate with strong scientific/technical leadership, able to handle several projects and processes simultaneously and effectively, and contributing to manage resources, is required.
* Good oral, written (scientific reports and filing documents), and presentation skills in English are required. Good knowledge of Dutch is desired.
* Primary location: Beerse - Antwerp - Belgium
Janssen Pharmaceutica N.V. (7555)