Celerion is committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Track, prepare, and account for all investigational products. Act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice.Please note: Registered Pharmacist required.
Essential Functions Responsible for receipt, storage, preparation, disposition, and retention of all study investigational products in compliance with standard operating procedures, FDA, and DEA regulations concerning investigational product handling, accountability and security. Review and understand study protocol requirements in regard to investigational product handling.Active member of study team providing expertise and support such as evaluating study feasibility, study set up and conduct, participating in internal and/or external client meetings. Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.Knowledge of relevant United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required.Maintain aseptic compounding evaluation requirements.Provide training and monitoring for administration of investigational products as needed.Review and provide input to standard operating procedures and training plans pertaining to pharmacy and assisting with pharmacy training as necessary.Maintain pharmacy department equipment and applicable records as necessary.Institutional Review Board consultant and resource.Assist in training of new hires and students. Additional Essential Functions if assigned the “Designated Person” role:
Work with the Pharmacist in Charge to: o Ensure compliance with current USP guidelines and applicable Celerion SOP’s pertaining to extemporaneous pharmacy compoundingReview applicable compounding SOP’s every 12 months to ensure continued compliance with USP guidelines and implement changes, as appropriateEnsure the CAPA system is initiated when warrantedOversee pharmacy personnel compounding training programOversee compliance with USP guidelines Oversee monitoring of the Designated Compounding AreasReview and maintain all pharmacy compounding certification records (personnel and facility) to ensure completeness and complianceRecognize problems, deviations, failures, and errors in the compounding process and the facility and report all issues to the Pharmacist in Charge Requirements Registered Pharmacist requiredDoctor of Pharmacy preferred but not requiredProven pharmaceutical experience of minimum 1-2 yearsProven record keeping skills with extreme attention to detailKnowledge of United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs requiredCompletion of media bi-annual media fill and fingertip testing (as applicable per site)Knowledge of FDA and EU regulations preferred (if appropriate)Job-specific training is required and will be providedFull time positions - requires flexible work hours for early morning and occasional on-call weekend availability Additional Information Celerion Values: Integrity Trust Teamwork Respect
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Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
