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.
Job Purpose:
Track, prepare, and account for all investigational products. Act as a resource for study teams by utilizing
pharmacological expertise and knowledge of pharmacy practice.
Essential Functions: Responsible for staff management in accordance with the organization's policies and applicable laws.Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employeesKnowledge 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.Responsible in conjunction with the Designated Person for ensuring compounding suites are maintained and certified on an ongoing basis.Management of pharmacy schedule and assignment of studies.Responsible for receipt, storage, preparation, disposition, and retention of all study drug products in compliance with standard operating procedures, EU, FDA, and DEA regulations (as applicable) concerning investigational product handling, accountability and security. Review and understand study protocol requirements in regard to investigational product handling. Preparation of study specific pharmacy manuals for any type of compounding studies.Overall responsibility for pharmacy operations.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.Ensure EU, Controlled Drug, and DEA license (if applicable) is current and all federal and state laws pertaining to prescription medications are being followed. Interact with all applicable regulatory agencies, as necessary, regarding investigational product and investigational product supply handling.Track and maintain appropriate pharmacy metrics as necessary, including retention follow up/invoicing.Track and manage pharmacy expenses including supplies, fees, contractors, and payroll.Provide training and monitoring for administration of investigational products as needed.Develop and review standard operating procedures and procedure guides pertaining to pharmacy and including pharmacy training as necessary.Maintain pharmacy department equipment and applicable records as necessary in conjunction with the lead pharmacy technician.Document and report any and all pharmacy deviations and implement process improvement changes as applicable.Institutional Review Board consultant and resource.Assist with special projects as needed.Active member in the clinic leadership team and attending management meetings as necessary. Knowledge/Skills/Education/Licenses 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 required.Completion 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 provided Additional Information Celerion Values: Integrity Trust Teamwork Respect
Are you ready to join our team?
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.
