Due to our continued growth, Corium Innovations is seeking an R&D Principal Scientist who will lead a highly motivated team through method development, qualification and optimization supporting existing and future drug products. This position requires method development and qualification experience for both liquid and gas chromatography (HPLC and GC) and will be responsible for leading laboratory investigations, implementing corrective actions, supporting regulatory filings and serving as the subject matter expert for method qualification during regulatory audits. Your most Innovative career move is here! At Corium Innovations, we’ve led the way in innovating drug delivery technologies for millions of patients whose GI systems just can’t tolerate pills, who can’t remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There’s so much more to deliver, and we need YOU to do it! Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last. - 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.
- Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.
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