Product Implementation Specialist

Job Description

Job Description

Division Department :

PharmaLogic Technical Operations Product Development & Implementation

Position Title :

Product Implementation Specialist

Reports To :

Director of Product Development & Implementation

Location :

Cincinnati, OH - Work from home opportunity with 50-75% travel required.

Role Summary :

The Product Implementation Specialist will play an essential role in the implementation and validation of new and existing positron emission tomography radiopharmaceuticals.

The position will have hands-on experience with the manufacture and quality control testing of radiopharmaceuticals produced on automated radiochemistry synthesizers and tested using analytical chemistry instrumentation.

Job Responsibilities and Duties :

• Leads onsite radiochemistry activities :
• Contributes to the PharmaLogic culture
• Translates new products from development to implementation throughout the network.
• Synthesis of generic and novel PET radiopharmaceuticals.
• Method validation / verification of analytical methods for HPLC, GC and TLC among others.
• Maintain experience with broad range of technologies including :
• Automated radiochemistry synthesis units such as GE FASTlab 2TM, Trasis AllInOneTM and similar.
• Analytical Chemistry Instrumentation such as HPLC-UV / VIS, GC-FID, rTLC, and similar.
• Work with appropriate site personnel to install, qualify and maintain equipment on-site.
• Assist with improvement of current cGMP and non-cGMP processes.
• Follow all SOP guidelines for QC release testing of radiopharmaceutical product, raw material, finished and semi-finished product, environment, and facilities.
• Maintain clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations.
• Maintain accurate production and test / validation results.
• Effectively communicate all issues related to safety, quality, and compliance to Quality Assurance and leadership
• Perform other job-related duties as assigned.

Job Requirements Education :

• Master’s degree in chemistry or related field preferred.
• Bachelor’s degree in chemistry required along with equivalent industry experience.
• Hands-on experience in a cGMP environment is required. Strong preference will be given to radiopharmaceutical industry experience in 21 CFR Part 212 or 21 CFR Part 211 spaces.
• Experience with laboratory methodology (HPLC, GC, TLC, and ICP) in a radiochemistry setting highly favored.
• Experience with US FDA cGMP, Radiation Safety Principles, isotope handling and analytical equipment troubleshooting and maintenance a plus.
• Superior teamwork, multi-tasking, and time / project management skills.
• Excellent communication, analytical, problem solving, presentation and computer skills (including proficiency in Microsoft Office and related software).
• Ability to work varying shifts with 50-75% travel is required.
• Mechanical aptitude, manual dexterity for manipulating small items, ability to lift between 15 to 50 lbs. are required.
• Ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment;

demonstrate effective organizational skills; commitment to continuous learning; an ability to work well both independently and as part of a team are required.

Come join our winning team and begin a fulfilling career with us by applying today.

PharmaLogic is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

Benefits Include :

401(k) retirement benefit program

Medical

Dental care

Disability insurance

Employee assistance program

Life insurance

On-site parking

Paid time off

Vision care