Formulation Scientist, P&L, DPDS-DPD, Beerse
Parenterals and Liquids group is a department of Small Molecule Pharmaceutical Development – Drug Product Development (SMPD - DPD). The department is responsible for end-to-end liquid 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 plant and commercial 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 drug delivery systems
Description of the function
The Formulation Scientist will play an important role to lead/support 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 Formulation Scientist will support regulatory submissions of new and existing drugs and involve dossier preparation.
The Formulation Scientist will be accountable in the early phase of formulation/process development of new oral liquid and sterile liquid pharmaceutical products for SMPD 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.
She/He will work together with different departments e.g. the Pharmaceutical Science, Analytical Development, Pilot plant, Scientific Integrator in developing drug products suitable for Tox study and clinical studies.
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 basic knowledge and experience in liquid and parenteral formulation development especially for poorly soluble compounds, designing suitable processes (e.g. sterile/aseptic, micro-/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 technicians in development activities.
The successful candidate should possess good interpersonal, scientific leadership, project management, and problem-solving skills and the ability for high performance in a matrix environment.
• A PhD with 3 years or Master degree with 7 years relevant 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 2-3 projects and processes simultaneously and effectively, and contributing to manage resources, is required.
• Good oral, written (scientific reports/documents), and presentation skills in English are required. Good knowledge of Dutch is desired.
• Primary location: Beerse – Antwerp – Belgium
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen Pharmaceutica N.V. (7555)