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Pharmaceutical and Nonclinical Development Project Manager
Не указаноПолная занятостьDrug Product DevelopmentBiopharmaceuticals
Join a pharmaceutical and nonclinical R&D team to carry out hands-on scientific development and coordinate project activities, from early formulation concepts through clinical development and product approval. The role has no direct team-management responsibility.
Обязанности
- Design and conduct formulation, process-development, scientific, biochemical, and method-development studies, including GMP validation activities.
- Perform laboratory work, including formulation preparation and aseptic work.
- Prepare study plans and protocols using regulatory guidance, scientific evidence, project objectives, timelines, and budgets.
- Develop, qualify, and validate methods and processes in line with regulatory guidance and project needs.
- Analyze, interpret, and present scientific data; maintain raw-data records and prepare protocols, reports, and development documentation.
- Troubleshoot scientific and operational issues and help improve methods and processes.
- Coordinate external CROs and service providers, including defining scope, tracking progress, monitoring performance, and reviewing results.
- Work with Analytical R&D, Operations, Quality Assurance, and Regulatory Affairs to advance project deliverables.
- Support regulatory activities and submissions for pharmaceutical and nonclinical development projects.
- Prioritize parallel scientific activities and meet agreed timelines.
Требования
- Ph.D. in a relevant scientific field and at least 3 years of pharmaceutical or biotechnology R&D experience, or an M.Sc. and at least 6 years of such experience.
- Experience leading scientific or pharmaceutical development projects, with formulation or manufacturing-process development experience; clinical- or commercial-stage experience is preferred.
- Knowledge of pharmaceutical development guidelines, including GMP, GLP, and ICH, and familiarity with process and method validation principles.
- Experience working with and managing CROs or other external service providers.
- Fluent spoken and written English.
- Strong scientific problem-solving, organizational, writing, communication, and interpersonal skills; able to work independently and collaboratively and manage multiple activities.
Будет плюсом
- Experience with aseptic techniques and biochemical or enzymatic assays.
- Experience with biologically derived or enzyme-based products.
- Experience with sterile drug products, sterilization of excipients or raw materials, packaging development, or container closure integrity testing.
- Experience with Design of Experiments and statistical data analysis.