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The Chemist will support both 503A and 503B efforts of compounding pharmacy operations by leading R&D initiatives, overseeing sterile and non-sterile third-party testing programs, and supporting site standardization and compliance activities. This role is responsible for developing scalable, compliant compounded drug products while ensuring alignment with USP, FDA, and cGMP requirements. In addition to hands-on development and testing oversight, this position will play a key role in establishing and building the company’s internal analytical laboratory. The Chemist will help define analytical capabilities, develop testing methods, and implement systems and workflows to support ongoing product release, stability, and investigative testing. This role will also contribute to building and mentoring an internal R&D and analytical team as the organization grows.
Job Responsibility:
Manage all sterile and non-sterile third-party testing communication activities, including method selection, sample coordination, data review, and vendor qualification
Leading/developing our in-house analytical lab upon site-readiness
Design and execute R&D studies, including formulation feasibility, stability, compatibility, and process development and manage R&D direct reports
Establish analytical workflows, SOPs, and best practices to support long-term business growth
Adjusting MFR methods of preparation to reflect formula/quality optimization
Verifying stability and compatibility of ingredients
Reviewing and developing compound formulations
Supporting staff training on best practices
Ensuring adherence to USP guidelines
Acts as a key resource for maintaining product efficacy and aligning with compliance and regulatory standards for customized medication preparations
Willingness to travel to site locations up to 25%
Working cross functionally with all departments within the enterprise
Requirements:
Advanced degree in Pharmacy, Medicine, Life Sciences, or related field (PharmD, MD, PhD)
Ability to work independently, prioritize tasks, and adapt to changing priorities in a fast-paced environment
Excellent communication, presentation, and interpersonal skills with the ability to effectively engage with diverse audiences
Experience within the analytical lab setting
What we offer:
Employer paid healthcare coverage available after 30 days of employment
Choice of an FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching contributions
Weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members