Savara Pharmaceuticals is seeking a high energy individual to fill a laboratory-based role in its formulation and analytical development laboratories.
The successful candidate should be comfortable working in a start-up company and have experience supporting formulation, analytical, process development and manufacturing activities.
This person should have extensive experience working in a regulated environment and be comfortable with the documentation and experimental rigors thereof. The position reports to the Sr. Director, Pharmaceutical Development.
Essential Duties and Job Functions
• Manage day to day laboratory operations.
• Manage the laboratory notebook and technical report SOPs.
• Conduct formulation, analytical and process development studies.
• Prepare documentation and formal reports in accordance with current standards and where appropriate to GMP.
• Generate CMC documents for regulatory submissions or enquiries.
Requirements
• B.S. in chemistry, pharmaceutics, or related field.
• Extensive experience working in a regulated pharmaceutical environment.
• Good familiarity with R&D, cGLP and cGMP requirements.
• Experience managing laboratory operations.
• Experience in analytical method development and validation would be preferred.
• Experience with solid dosage forms desired. Experience with pulmonary drug delivery formulations would be advantageous.
• Experience in early development phases of the drug development process.
if interested, please contact: Brian Riley | RG Search | 512-789-6488 | brian@rgsearch.com
