Celebrate Individuals:

We're looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.

Successful Together:

We believe we're better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.

Embrace Innovation:

We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners. Pride in

Ownership:

We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!

Responsibilities:

Plans, designs, and oversees analytical method life-cycle activities through multiple stages of development. Accountable for technical oversight and phase-appropriate development, qualification/ validation, re-assessment, and transfer of chromatographic and physical methods targeted for raw material, in-process, release, and stability testing of early and late-stage development programs. Contributes expertise on data interpretation, instrumentation, and trouble shooting. Tracks analytical method performance and implements analytical method remediation measures, when required, from early data signals. Support laboratory-related root cause analysis and unexpected results (OOS/OOT) investigations. Contributes expertise to stability study and comparability study design. Implements and facilitates training for Corium Innovations staff members on best practices. Support of CMC regulatory filings. Works closely with internal collaborators. Provides expertise, technical leadership, and assessment of product quality impacting non-conformance and out-of-specification investigations. Adheres to all department and company-wide policies regarding conduct, performance and procedures. Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization's policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities. Performs other duties as required.

Qualifications:

Bachelor's degree in chemistry, biochemistry, or related field and a minimum of 15 years of related, progressively responsible experience in analytical development in the pharmaceutical industry. Master's degree with 12 years of experience or a PhD with 8 years preferred. Knowledge of USP, ICH and FDA requirements. Extensive experience with HPLC/UPLC, GC, wet chemistry techniques and USP methods. Analytical method validation/development experience in the pharmaceutical industry. Experience conducting technical investigations into out of specification, aberrant, or unexpected results. Experience in Dissolution, IVRT/IVPT method development and validation. Excellent communication skills, both verbal and written. Ability to troubleshoot technical issues. Ability to operate in a flexible, team-based environment. Experience in transdermal products preferred. Promotion and support of quality culture throughout the organization. Strong organizational skills and attention to detail. Excellent communication and presentation abilities. Proficiency with MS Office suite. Ability to eliminate inefficiency and drive innovation. The ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization's expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Benefits:

Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program. 401(k) retirement savings account with a company match and immediate vesting. 12 paid holidays. 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