QUALITY CONTROL ANALYST I, PHARMACEUTICAL TESTING
PTx is devoted to developing and commercializing medicines and combination therapies that can make a meaningful difference in the lives of patients with cancer and other serious diseases. We are united in our passion for improving the treatment of cancer and other diseases and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.
PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art Northpointe (NP) manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. PTx is a small company full of opportunities and ambition and we need outstanding people to join our team to help realize our mission.
This position is responsible for the performance of standard quality control assays that supports the release and stability testing of Leukine product. .Additionally, this position is responsible for the timely performance of supporting laboratory functions, data processing, and documentation, and operates in compliance with procedures and cGMP regulations.
POSITION OVERVIEW/KEY RESPONSIBILITIES:
LABORATORY TESTING AND SUPPORT (75%)
* Performs standard QC procedures, data processing, and analysis in compliance with cGMP
* Assists in the qualification of critical reagents and instruments.
* Maintains inventory of critical reagents, chemical reagents and laboratory supplies
* Provides efficient, effective and timely analytical support to both internal and external customers while prioritizing activities as necessary to meet the work schedule deadlines
* Maintains laboratory, including, but not limited to: washing glassware, preparing buffers, and helping perform routine maintenance on equipment and instruments
* Initiates, completes, and helps maintain GMP documentation (i.e. SOPs, laboratory investigations, change controls, deviations, etc)
* Performs data entry to support product release
* Provides testing support in the development of new quality control test methods.
* Provides testing support in method validations or method transfers.
* Adheres to department standard operating procedures
* Maintains an awareness, responsibility and accountability for current GMP and SOP requirements
* Follows safety precautions in the laboratory
* Investigates and documents any deviations
* Follows Skills Inventory system to meet current training requirements per the established schedule and train on new procedures/requirements as required
* Prepares/revises laboratory SOPs, test methods, protocols and change control documentation in
cooperation with QC Laboratory Management and Compliance departments
* BA/BS Degree in Microbiology, Biology, Chemistry or Biochemistry
* 1 – 2 years of QC experience preferable
Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life INS, 401(k) with match & PTO
To be considered for the position, please send your resume to