Job Description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

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

This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Pharmacist in the DMID government contract provides support and investigational agent distribution for government clients, DMID monitors the product/protocol/project from initiation through delivery, interfacing with customer on all pharmaceutical related matters.

Essential Duties and Responsibilities:

• Reviews clinical site orders, supports clinical protocols and calculates supply requirements.
• Manages supply levels and expiration date of products, interacting with pharmaceutical manufacturers, communicating with clinical sites, and involvement with packaging and labeling investigation agents.
• Develop and revise SOPs to support operational activities.
• Manage and approve Investigational drug orders.
• Monitor quantity and expiration date of supplies being issued.
• Prepare documents for international shipments and/or apply for FDA import permits.
• Review monitoring reports, pharmacy licensing, notify project Officer of clinical site problems, and maintain database containing a review of all pharmacy contract related items.
• Support proper shipping and distribution of Investigational agents to clinical sites.
• Check and review processed orders.
• Process and investigate any customer complaints or deviations.
• Attend COR meetings and provide updates on study protocol.
• Purchase pharmaceuticals or vaccines to support clinical trials under IND through approved vendors.
• Provide compounding solutions for future clinical trials.
• Initiate and authorize product recalls.
• Review Certificates of Analysis (CoAs) for clinical agents.
• Establish drug requirements and supply requirements for new protocols.
• Design and create drug labels based on country and regulatory requirements.
• Review protocol revisions for impact on inventory levels and update the COR.
• Research and facilitate purchasing of study products by the networks.
• Develop packaging and labeling requirements to meet US and International packaging and labeling standards.

• Review batch records for accuracy.

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,
• Requires knowledge of federal, state, and/or international regulation as they apply to products, processes practices, and procedures.
• Requires knowledge of 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 operational 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.

Compensation and Benefits

The salary range estimated for this position based in Maryland is $91,700.00–$137,525.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards