Pharmacist

Thermo Fisher Scientific • Rockville, MD

33d

About The Position

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. Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Pharmacist III in the Clinical Research Products Management Center (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).

Requirements

• 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.
• 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.

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.
• Screen, manage, and approve Investigational drug orders.
• 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 and review processed orders.
• Maintain inventory records via COSMOS.
• Process and facilitate customer complaints.
• Conduct surveys to the clinical research sites when requested by NIAID/DAIDS.
• Distribute mass deliverables to the clinical research sites when requested by NIAID/DAIDS.
• Serve the primary liaison to clinical site pharmacists.
• Attend and be able to document Meeting Minutes for weekly and ad-hoc meetings with NIAID/DAIDS, manufacturers, pharmaceutical partners, and clinical research sites.
• 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 files for program protocols including but not limited to the required TMF artifacts and Clinical Supply Plans in the contract's shared drive and in the Veeva Vault system.
• Design and create drug labels based on country and regulatory requirements.
• Review protocol revisions for impact on inventory levels and update existing drug supply statements and Clinical Supply Plans.
• Research and facilitate purchasing of study products by the networks.
• Develop packaging and labeling requirements to meet US and International packaging and labeling standards.
• 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.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level