PTx is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer 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 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. To get there we need outstanding people to join our team of talented, innovative and committed professionals.
The Process Science/Analytical Lifecycle Management Department is composed of scientists and engineers who are responsible for the development, maintenance and remediation of the production process and analytical methods performed by QC. Activities include performing scale-down modeling of the process, screening of raw materials and updating and re-validating analytical methods to current standards.
POSITION OVERVIEW/KEY RESPONSIBILITIES:
* This is a development position.
* Reports to head of Process Science/ Analytical Life Cycle Management
* Interacts with members of QC, PS/ALCM, Production and Validation
* Project management experience preferred
* Brings 15+ years of method development, qualification and validation experience
* Demonstrated expertise in the development of bioassays, particularly cell-based proliferation and/or gene reporter assays
* Extensive tissue culture experience, particularly with immortalized and/or genetically modified cell lines
* Experience with method transfer to QC for release testing of biologics in a GMP environment
* Ability to work independently
* Responsible for experimental design and execution as well as data interpretation
* Ability to perform statistical analysis
* Writing and reviewing of development reports and qualification/ validation protocols
*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
LEADERSHIP QUALIFICATIONS: ☐ N/A if this position does not have direct reports.
This role currently has no direct reports to manage, but they must embody considerable leadership skills to be successful (including effective intrapersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability).
* Bachelor's Degree and at least 5 years working in analytical method development for biologics
* An advanced degree in a biological science or engineering
* Demonstrated strong organizational, interpersonal and project management skills
* Demonstrated ability to work independently and provide some leadership
* Strong technical writing skills and experience drafting validation protocols
* Familiarity with ICH and FDA Guidelines for method development and validation
* Hands on experience with analytical bioassay method development and transfer to or implementation in a commercial GMP environment.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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