Contamination Control Specialist

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.

Contamination Control is responsible for providing microbiologic expertise, investigative services and contamination control leadership ensuring that the site maintains robust aseptic control over the manufacturing environment. Contamination Control will accomplish this by providing the necessary customer support and quality oversight of processing, environmental monitoring, cleaning and disinfection, access and flow, gowning, facilities and utilities programs.

POSITION OVERVIEW/KEY RESPONSIBILITIES:

The Contamination Control Specialist will provide support for microbial excursions, quality systems (deviations, laboratory investigations and CAPA activities), risk assessments, and impact assessments related to routine production.  This role is expected to enhance the presence of contamination control on the production floor and help identify potential issues to ensure continued compliance and audit readiness state.   This role is expected to serve as the backup to the department lead to ensure a department representative is always available to address urgent issues and/or contamination events as they arise.  This role must also possess the following:

  • Leadership Abilities:  Strong analytical, problem solving, and communication skills (verbal and written), and great time management skills

  • Flexible, embracing new tasks and challenges with positivity

  • Ability to work with cross-functional teams to provide contamination control expertise

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.

  • Being honest and treating people with  respect and courtesy​

BASIC QUALIFICATIONS:

  •  B.S. in Microbiology or equivalent life science

  • Minimum of 5-10 years working in GMP industry

  • Sound understanding and experience performing basic microbiology testing (i.e. environmental and utility monitoring, bioburden testing, and water testing).

  • Experience writing and reviewing technical documents and reports (e.g. SOP revisions, Environmental Qualifications, and EM and Utility Trend Reports)

  • Self-Motivating with ability to work independently with minimal supervision

  • Ability to receive and provide constructive feedback, communicate intent clearly, escalate stuck issues quickly to ensure success, and ability to act with urgency to meet customer, department, and business needs

PREFERRED QUALIFICATIONS:

  • Demonstrated contamination control experience

  • Experience performing microbial identifications

  • Strong project management skills

  • Knowledge of Risk Assessment Tools (e.g. FMEA, HAACP)

  • Experience conducting training classes to share knowledge and educate others

  • Strong knowledge of industry regulations and ability to seek and pursue current  industry best practices and trends

SPECIAL WORKING CONDITIONS:

  • Ability to perform GMP Gowning Activities.

To be considered for the position, please send your resume to Brooklyn.borges@partnertx.com  or Justin.hoeker@partnertx.com 

Job Type: Full Time
Job Location: Lynnwood WA

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