Sr. Scientist – Analytical Development
The Sr. Scientist of Analytical Development will be responsible for supporting development of analytical methods at the Jaguar Process Sciences lab in Cary, NC and at third-party laboratories. The Sr. Scientist will be a Subject Matter Expert on a subset of analytical methods and provide support in managing third parties performing these methods. This role will require execution of tests inside the Analytical Development laboratory, data analysis, technical report writing, and third-party management.
This role will report to the Manager of Analytical Development and will work closely with the other Jaguar functional leads to ensure end-to-end GMP compliance and continuity across the manufacturing and testing network. As a small company, this individual will need to think strategically but will also be required to have a “hands on” approach to routine activities ensuring that day to day functions are executed in a timely manner.
General Position Summary/Purpose
- Serve as a technical SME and method owner for a subset of tests performed at Jaguar and third-party laboratories
- Support regulatory submissions as a subject matter expertise for analytical methods
- Perform analytical development experiments to support new Gene of Interest targets, method development activities and method optimization
- Support third-party management as a technical point of contact. Provide technical review of data, protocols, and reports. Participate in regular meetings with third parties.
- Lead Analytical Development projects from design through execution and closure
- Provide training and technical support to all partners involved in the analytical testing network including third-party laboratories, suppliers, consultants, and internal staff
- Utilize project management tools to help track analytical method development across varying products and laboratories
- Minimum of 3-5 years of experience in Biotechnology GMP manufacturing in Analytical Development, Research or Quality Control
- Understanding of cGMPs and pharmaceutical industry procedures and regulations specifically working with biological drug products.
- Expertise in Biochemistry and analytical chemistry with focus on methods such as: ELISA, Capillary Electrophoresis, LCMS
- Strong laboratory experience and skills
- Experience working in a fast paced, start-up environment
- Strong, open, and transparent communication skills (verbal and written), including excellent presentation skills
- Strong project management and time management skills
- Experience with MS Excel, Word, MS Project, and MS PowerPoint is a plus
- Ability to travel – up to 25%
Education Requirements (Degree, Certifications, Etc.)
- Undergraduate degree in chemistry/biology or relevant science
- Graduate degree preferred, PhD or MS in Biochemistry, Analytical Chemistry or related discipline