Associate Director, Analytical Development and Validation
The Associate Director, Analytical Development and Validation will be responsible for the identification, development, validation and transfer of the Company’s analytical test methods for raw materials, packaging components, drug substances including new chemical entities and drug products. This position will lead the development, validation and transfer of new and existing characterization techniques. The role will collaborate cross-functionally with the technology team, product operations, quality assurance, regulatory and other key stakeholders. This position shall adhere to the Company’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.
1. Lead the development and validation activities for raw materials, packaging components, drug substance and drug product test methods.
2. Lead method transfer to internal and/or external partners, including protocol and report generation. Collaborate cross-functionally with QA and Product Operations to support out of specification, out of trend or anomalous results, investigations and deviations as needed.
3. Recommend approaches and strategies to aid in overall project success. Solve problems with methods, instruments, or processes and interpret data to draw conclusions and make recommendations.
4. Foster an environment of open communication and information sharing within and between teams. Work closely with Management to ensure proper resource allocation within and across teams. Provide mentoring/training and development to less experienced scientists. Responsible for supervising direct reports.
5. Create standard operating procedures for new or existing analytical equipment, performing IQ/PQ/OQ, troubleshooting, preventative maintenance and calibration of analytical laboratory equipment, and leading the interpretation of data when appropriate.
6. Manage the stability program for drug substance and drug product candidates which includes balancing company resources to meet project timelines and working closely with Product Operations to ensure seamless data sharing with key stakeholders.
7. Perform analytical testing of raw materials, packaging components, drug substances and drug products.
8. Implement GXP practices when appropriate and adhere to Novan’s Quality Systems in all work performed and author relevant technical documents. Must have strong, demonstrated commitment to and understanding of data integrity.
9. Maintain a thorough understanding of regulatory requirements for developmental and commercial phases of projects (i.e. ICH, FDA, USP, Ph.Eur.). Understand and follow all procedures and processes required for work performed under cGMP. Ensure all work is performed and documented according to approved SOPs in compliance with cGMP and in a timely manner consistent with agreed upon schedules. Comply with internal and customer SOPs as required.
10. Follow good laboratories practices, according to Novan’s procedures, including maintaining updated and accurate laboratory notebooks.
11. Perform other duties as assigned.
- Practical experience in some of the following instrumentation and techniques are required: gas chromatography, high performance liquid chromatography, ultra-high pressure liquid chromatography, ion chromatography, spectroscopy, viscometer, rheometer, pH meter, particle size analyzers, Graphite Furnace-AA, basic wet chemistry, coulometric Karl Fischer titrations and TGA.
- Proven excellence in driving both internal and external projects to completion
- Experience in both early and late stage pharmaceutical, bio pharmaceutical or biotech drug development
- Supervisory experience strongly preferred
- Extensive experience using chromatography data systems, Empower Super User preferred
- Familiarity with bio analytical method development, validation and GLP regulations preferred