Director, Analytical Development
The Analytical Development Director will report directly to the Sr. Director of Analytical Development and will provide strategic planning and management for selected projects and departmental initiatives. The incumbent will provide supervision and mentorship to analytical development staff members engaged in analytical development activities supporting drug substance and drug product development enabling first-in-human trials through post approval changes to marketed products.
Demonstrated expertise in several key technologies such as HPLC/UPLC, LC-MS, vibrational spectroscopy, High-Field NMR, solid state characterization (DSC, TGA, PXRD), and or chemometrics is an essential requirement of the position. The incumbent will be accountable for growing capabilities in such technologies as they aligned with Neurocrine’s business objectives. The incumbent must be comfortable performing experimentation in the laboratory individually and to coach the technical staff.
The incumbent will be required to effectively interact with multiple functions across the organization, and effectively communicate results and strategies to staff and company executives. The incumbent will be skilled in the application of the cGMP and appropriately apply these between regulated and non-regulated activities.
Supervision of scientists and 3rd party development partners will be routinely performed. The ability to travel domestically and internationally with short notice is expected.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
- Oversee 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous results.
- Review of internally and externally generated raw data.
- Appropriately apply the cGMP between regulated and non-regulated activities.
- Collaboratively plan and execute cross functional studies for chemical development and formulation development.
- Independently plan, execute, and justify in-house stability studies for drug substances, intermediates, and prototype drug products.
- Recognize and respond to unexpected or anomalous observations in all activities.
- Ensure records of laboratory work are complete, accurate, and in conformance with company SOPs and training.
- Travel, when necessary, to 3rd party manufacturing and/or testing sites.
A M.S./ Ph.D. in a relevant scientific discipline (analytical chemistry preferred) and 12 + years of related technical and management experience in the pharmaceutical industry. Directors must have strong fundamental knowledge of analytical chemistry, pharmaceutical analysis, hands-on experience with chromatography and other core analytical techniques, a good understanding of phase driven drug development, cGMP and familiar with guidance and policies from a variety of organizations (FDA, EMA, PMDA, ICH, etc.) and the overall CMC regulatory environment’s expectations for CMC.
Excellent communication skills are expected as is prior supervisory and/or laboratory mentorship experience leading an analytical team.
- Proficient using MS-Office, experienced with common data systems for computer controlled instrumentation (e.g. Waters, Agilent, Nicolet, TA).
- Significant theoretical and practical experience in several key technologies routinely applied to pharmaceutical and chemical analysis.
- Good cross-functional understanding related to drug substance and drug product development
- Significant practical experience conducting method transfer both as the originating and receiving site
- Significant experience evaluating analytical data and drawing meaningful conclusions
- Strong attention to detail, excellent written and oral communication skills
- Experience working in a timeline driven setting
- Knowledge of cGMP expectations for laboratory records and quality systems
- Ability to provide ideas for process improvements, and the enthusiasm to implement
- Ability to work with a team of individuals to meet organizational goals