MANUFACTURING ASSOCIATE

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.

 

Production is responsible for sargramostim API manufacturing operations at Genzyme’s Northpointe site, a production scale therapeutic protein manufacturing facility.API Production is divided into Upstream Operations (Fermentation) and Downstream Operations (Purification).In either area, operational staff is involved in cleaning and sterilization of process equipment, autoclaving, buffer and media preparation, aseptic processing, operating process equipment and supporting cGMP operations. Upstream staff focuses on managing and running fermenters and filtration equipment, downstream staff focuses on HPLC and low pressure Chromatography equipment.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This position is responsible for performing a variety of simple and medium complexity tasks under general guidance and in accordance with current GMP's. 

Responsibilities include:

  • Operating process equipment such as large scale fermenters and chromatography skids.

  • Operating support equipment such as autoclaves, media and buffer preparation equipment.

  • Performing clean in place and steam in place operations to prepare equipment for manufacturing operations

  • Identifying and troubleshooting routine issues and defects

  • Escalating issues to a supervisor or higher level co-worker

  • Assisting in the review & creation of operation documents by providing input to technical composition of document

Effectively demonstrates an understanding of GMPs & strictly follows both local and corporate cGMP requirements and standards.

  • Following accurate oral & written procedures in operating production equipment & performing processing steps

  • Maintaining orderliness of process area

  • Monitoring operations to ensure compliance with process specifications

Practices safe work habits and adheres to Genzyme’s safety procedures and guidelines.

Train new employees.

Utilizes manufacturing knowledge to improve process operations and affect positive change.

 

BASIC QUALIFICATIONS:

  • High School Diploma and at least 4 years of experience in a cGMP manufacturing environment

 

PREFERRED QUALIFICATIONS:

  • Bachelor’s Degree in a Science related field (eg. Biology, Chemistry, Chemical Engineering) and at least 4 years of experience in a cGMP manufacturing environment

  • Previous departmental experience in Fermentation and/or or Purification operations gained through Senior Manufacturing Technician level position

  • Experience reviewing and creating controlled documents

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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