PROCESS SCIENCE STAFF SCIENTIST 

 

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 an assay development, characterization, and assay support position

  • Reports to Analytical Life Cycle Management team lead

  • Ability to work independently

  • Brings 5-10 years of development experience

  • Demonstrated expertise with HPLC, CE, and other routine analytical methods for recombinant

protein analysis

  • Experience with peptide mapping and LC/MS desirable

  • Responsible for experimental design and  execution as well as data interpretation

  • Maintenance of lab, reagents and equipment

  • Writing and reviewing of development reports and qualification/ validation protocols and reports

  • Interacts with members of QC, PS/ALCM. Production and validation

 

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 leadership skills to be successful (including effective intrapersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability.)

 

BASIC QUALIFICATIONS:

  • Bachelor's Degree in Science or Engineering and 10 – 15 years of working experience in Process Development for Biologics

  • Master’s degree in Science or Engineering and 5 – 10 years of working experience in Process Development for Biologics

  • Ph.D.  in Science or Engineering and 2 – 5 years of working experience in Process Development for Biologics

 

PREFERRED QUALIFICATIONS:

  • Demonstrated strong organizational, interpersonal and project management skills

  • Demonstrated ability to work independently and provide some leadership

  • Strong writing skills and experience with validation protocols

  • Familiarity with ICH and FDA Guidelines

  • Hands on experience with semi-preparative chromatography and membrane technology as well as analytical methods

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 Justin.Hoeker@PartnerTX.com

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