Senior Manufacturing Associate

DEPARTMENT DESCRIPTION:

Production is responsible for sargramostim API manufacturing operations at Partner’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:

The Senior Manufacturing Associate performs cGMP commercial manufacturing of Leukine (sargramostim), a therapeutic glycoprotein. The primary duties of the Sr. Manufacturing Associate include:

  • Operation of manufacturing equipment (Fermenters, TFF systems, HPLC system, etc)
  • CIP and SIP of the same systems
  • Open processing
  • Media/buffer compounding

Because these activities are a component of cGMP commercial manufacturing, the following job conditions apply:

  • 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

When not engaged with manufacturing duties, the Sr. Associate will be responsible for the following:

  • Revision and creation of controlled documents
  • Maintaining training and acquiring new skills
  • Data Review
  • Reports, review and process improvements
  • Investigation lead
  • Quality Systems (lead for deviations, change control)
  • Batch Record Review

BASIC QUALIFICATIONS:

  • Bachelors Degree in Earth Science and at least 3 years of experience in a cGMP manufacturing environment or lesser degree and 4-7 years of relevent experience

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 Purification and/or Fermentation operations gained through Manufacturing Associate level position
  • Attention to detail – able to repeatedly perform tasks according to SOPs and Batch Records
  • Comfortable working with hazardous chemicals, steam, manufacturing equipment (safety controls are robust)
  • Intermediate statistics
  • Leadership skills
Job Type: Full Time
Job Location: Lynnwood WA

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