MANUFACTURING SUPERVISOR 

PTx is devoted to developing and commercializing medicines and combination therapies that can make a meaningful difference in the lives of patients with cancer and other serious diseases. We are united in our passion for improving the treatment of cancer and other diseases 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 Northpointe (NP) 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. PTx is a small company full of opportunities and ambition and we need outstanding people to join our team to help realize our mission.

Production is responsible for sargramostim API manufacturing operations at PTx  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:

The Manufacturing Supervisor oversees cGMP commercial manufacturing of Leukine (sargramostim), a therapeutic glycoprotein.  The supervisor is hands-on and spends the bulk of their time working directly with their team.  The primary duties of the supervisor include:

 

  • Floor lead for Manufacturing, overseeing day-to-day operations

  • Responsible for assessing daily needs providing support where needed

  • Training and Qualification of staff members

  • Communication upwards and downwards

  • Ensuring documentation requirements are consistently met

  • Batch Record Review

  • Quality Systems upkeep (deviations, CAPAs, Change Control, document revision)

  • Incident response

  • Ensuring safety procedures are followed

Because these activities are a component of cGMP commercial manufacturing, the following job conditions apply for both the Supervisor and the manufacturing team:

 

  • Gowning to work in a Grade C/D cleanroom (ISO class 7/8)

  • Training and qualification requirements, including proficiency assessments

  • Robust documentation requirements for activities

  • Deviation reporting

In addition to core manufacturing duties, the Supervisor will be responsible for the following:

 

  • Staff development

  • Representative for the team in various site workstreams

  • Budgeting

  • Review and approval of documents

  • Practices safe work habits and adheres to Partner Therapeutics safety procedures and guidelines.

  • Trains new employees.

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

  • Trains new employees.

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

*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

LEADERSHIP QUALIFICATIONS: ☒ N/A if this position does not have direct reports.

Leading People

  • PTx’s leaders motivate, inspire, build, and retain highly effective teams.  They manage for high performance and provide timely developing and coaching. They are versatile learners, focused problem solvers and courageous decision makers

Leading the Business

  • PTx’s leaders are effective operating in an evolving, complex and dynamic environment.  They provide clear direction and instruction to supervisors, direct reports and teams and continuously identify internal and external best practices and opportunities for improvement

PREFERRED QUALIFICATIONS:

The ideal candidate will have a Bachelor’s degree in Earth Science and 4-8 years relevant work experience (or a lesser degree and 6-10 years relevant work experience) and possess the following skills and traits:

  • Attention to detail

  • Excellent interpersonal skills (emotional intelligence)

  • Demonstrated ability to lead teams

  • Adept with GMP concepts and Quality Systems

  • Able to lift 15 kg

  • Comfortable working with hazardous chemicals, steam, manufacturing equipment (safety controls are robust)

  • Good writing skills

  • Intermediate statistics

DISCLAIMER:

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.  Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities.  This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

Please contact Brooklyn Borges at brooklyn.borges@partnertx.com or 425-245-1498 for all inquiries 

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Lexington, MA 02421

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