Partner Therapeutics (PTx) is a commercial biotech committed to improving the lives of patients with cancer and other serious diseases. 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. For more information, visit www.partnertx.com
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 Quality Microbiologist 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
*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
• B.S. in Microbiology or equivalent life science
• Minimum of 5-10 years working in GMP industry
• Sound understanding and proven experience having performed basic microbiology testing (i.e. environmental and utility monitoring, bioburden testing, and water testing).
• Experience authoring, revising, 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
• Understanding and experience performing risk assessments (Risk Management Tools
• Having initiated, designed, coordinated, and led training courses on microbiological and contamination control topics
• Ability to understand and translate regulatory and guidance documents (e.g. USP, IEST, PDA Technical Reports)
• 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
• Demonstrated contamination control experience
• Proven experience performing microbial identifications
• Strong project management skills
• Sound understanding and proven performance 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.
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