Job Description

At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com.
Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Pharmacist III in the CRPMC government contract provides support and investigational agent distribution for government clients, NIAID/DAIDS and monitors the product/protocol/project from initiation through delivery, interfacing with customer on all matters (NIAID/DAIDS).
Essential Duties and Responsibilities:
• Reviews and approves clinical site orders, reviews clinical protocols and calculates supply requirements.
• Manages supply levels and expiration date of products, interacting with pharmaceutical manufactures, communicating with clinical site pharmacists, conducting clinical site audits/visits, international shipping of investigational drugs, and involvement with packaging and labeling investigational agents.
• Develop and revise SOPs.
• Approve Investigational Agent Requests.
• Monitor quantity and expiration date of supplies being issued.
• Prepare documents for international shipments.
• Review monitoring reports, pharmacy audits, notify project Officer of clinical site problems, and maintain database containing a summary of all pharmacy audits.
• Supervise proper shipping and distribution of Investigational agents to clinical sites.
• Process and expedite emergency shipments.
• Check filled orders.
• Maintain inventory records via COSMOS.
• Process customer complaints.
• Serve the primary liaison to clinical site pharmacists.
• Initiate and authorize product recalls.
• Process product Certificates of Analysis (CoAs) and submit to the PAB QC Committee, NIAID/DAIDS, for product review.
• Establish drug requirements for new protocols.
• Create drug supply statements for new protocol.
• Maintain all reference documents related to program protocols
• Maintain files for program protocols.
• Design and create drug labels.
• Review protocol revisions for impact on inventory levels and update existing drug supply statements.
• Create and maintain formulary for those drugs maintained at the CRPMC.
• Provide CE training and lectures to other pharmacists and pharmacy technicians.
• Oversee CRPMC repackaging and labeling programs.
• Develop packaging and labeling requirements to meet US and International packaging and labeling standards.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action Employer
Disclaimer:
This position description is written as a guideline to inform Thermo Fisher Scientific Employees of what is generally expected of them at each job
level. The description is not intended to be all encompassing or limiting in any manner; rather, it is hoped it will add understanding and better
reflect the work performed at all levels of employment within Thermo Fisher Scientific. Duties and responsibilities other than those listed may be
included as needed within the work group or the company as a whole.
The above information is for exclusive use within Thermo Fisher Scientific and may not be used or duplicated by others without written consent.
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• Create and maintain batch records.
• As necessary, travel to CRS pharmacies for consultant visit or cause.
• Prepare and submit reports to DAIDS with results of visit
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
• Requires Good Manufacturing Principles, Joint Commission - Hospital Accreditation Standards, Good Clinical Practices and Maryland Pharmacy Laws for application in all areas of CRS operations.
• Requires knowledge of federal, state, and/or international regulation as they apply to products, processes practices, and procedures.
• Requires knowledge of import/export requirements for clinical study products.
• Requires analytical, research, written, editing, and verbal communication skills.
• Requires skills in medical discipline; Proficiency with computer word processing, label works.
• Requires proficiency using Internet tools to obtain technical reports from Government and other Web sites.
• Requires ability to effectively work and communicate with staff, and project personnel on technical issues.
• Requires strong organizational skills, detail oriented, and ability to work with multiple projects.
• Requires ability to work without supervision.
• Requires capability to resolve issues without promoting conflict.
Education/ Experience:
• Requires a Bachelor’s Degree in Pharmacy.
• Requires Maryland Pharmacy License (registered Pharmacist in the State of Maryland).
• Requires 3+ years of experience in the pharmaceutical field.
Certificates and/ or Licenses:
Requires Maryland Pharmacy License.
Supervisory Responsibility:
Assists with managing Pharmacy Staff in the absence of management.
Work Conditions/Physical Requirements:
• Must use personal protective equipment and adhere to safety protocols.
• Must be able to lift and carry up to 50 lbs.
• Must be able to work in walk-in freezers or refrigerators periodically.
• Must be able to use a computer up to 8 hours per day.
• Must be able to work in a laboratory and warehouse/repository environment.
• Must be able to travel locally and internationally for 5 days annually.