QUALITY CONTROL ANALYST II-BIOLOGICS & FACILITIES TESTING

 

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 Quality Control Biological and Facilities Testing group supports manufacturing activities at the Northpointe Facility by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. The group supports the environmental and critical utility monitoring program of the production facility and support areas.  The QC BFT group performs key microbiological assays supporting BDS, cell bank and drug product release. The QC BFT group routinely interacts with production, engineering, validation and other QC groups.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This individual will report to the QC Supervisor/Manager and will contribute to general operations and testing of the QC BFT lab. The QC Senior works independently under minimal supervision, but will participate with the QC team to meet group goals. Primary responsibilities include, but are not limited to, the following: Provide day to day training and direction to staff, support manufacturing and resolve and assist in resolving issues, troubleshoot and problem-solve laboratory issues,  perform assay validations, support critical utility and room releases, and represent functional area.  A successful candidate will have a proven ability to work with multiple departments.  Responsible for the implementation of new quality control procedures.  Investigates and resolves deviations.

 

Major Responsibilities and routine laboratory duties may include but are not limited to:

 

  • Perform critical utility monitoring of water, steam, compressed air, and compressed gas

  • Perform Environmental Monitoring within facility, including surface, particulate and viable air samples

  • Perform Biological Indicator Testing

  • Perform Endotoxin Testing

  • Perform Bioburden Testing

  • Perform Microbial Identification

  • Perform Media Qualification

  • Perform Sample Counting

  • Perform Cell Bank Testing

  • Participate in and perform special studies & projects assigned to microbiology

  • Assist in the development and optimization of testing methods

  • Enter data in LIMS, Apollo, and Observa database for review and trending

  • Make detailed observations in support of Alert, Action and OOS result investigations

  • Receipt and disposal of samples in the QC lab

  • Autoclave laboratory equipment in preparation for sampling and testing

  • General maintenance of Lab equipment and Controlled Temperature Units (CTU)

  • Troubleshoot assay and instrument problems with Laboratory Supervisor

  • Maintain log books and log sheets

  • Ensure labs are clean and safe (in compliance with CGMP) and properly stocked

  • Participate in the qualification of equipment, methods, and processes

  • Participate in writing and revising SOPs and protocols, and perform excursion investigation.

  • Lead equipment qualification (IQ, OQ,PQ).

  • Perform work that consistently requires independent decision making and the exercise of    independent judgment and discretion.

  • Provide training and technical leadership to less experienced staff.

  • Author complex documentation (protocols and technical reports).

  • Author quarterly environmental monitoring reports.

  • Prepare statistical analysis of results and write technical reports

  • Perform routine data review.

  • Perform validation and product data review.

  • Perform other additional job related duties, as required.

 

BASIC QUALIFICATIONS:

  • Bachelor’s Degree in Life Sciences discipline and 5-8  years’ experience in cGMP lab environment

  • Or

  • Master’s Degree in Life Sciences discipline and 3-6 years’ experience in cGMP lab Environment

  • Proficient in Outlook and MS Word and Excel and lab based data management systems

  • Scientific technical writing ability

 

PREFERRED QUALIFICATIONS:

  • Proficient in Outlook and MS Word and Excel and lab based data management systems

  • Experience working in a QC Microbiology department

  • Experience with environmental monitoring including water testing

 

SPECIAL WORKING CONDITIONS:

  • Must be able to lift 40 lbs.

  • Must be able to gown and gain entry to manufacturing areas

  • Must be available to work some weekends and occasional holidays

LEADING THE BUSINESS:

  • Operate in an evolving, complex and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.

 

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 Brooklyn.borges@partnertherapeutics.com

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Lexington, MA 02421

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