Manufacturing Associate III

Manufacturing & Supply Chain Bothell, Washington


Description

Summary: 

As part of the Downstream Manufacturing team, the Manufacturing Associate III completes production activities related to downstream purification of mAb drug intermediate and drug product in a cGMP environment.  The Manufacturing Associate III helps lead production activities in coordination with other associates and under supervision of the Manufacturing Supervisor.

Principal Responsibilities:

  • Performs downstream operations safely and compliantly in accordance with OSHA and cGMP guidelines.  Downstream operations include but are not limited to; dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, viral inactivation and filtration, product sampling, and filling of bulk drug product or intermediate
  • Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices
  • Performs oversight of process operations and monitors equipment and critical process parameters.  Utilizes production experience to articulate any production issues or abnormalities to management and other cross functional groups.  Provides insight and recommendations to address production issues and may lead resulting troubleshooting activities as necessary.  Takes a proactive approach to identify and address potential issues prior to their occurrence
  • Completes setup, use and cleaning (as necessary) of cGMP production equipment
  • Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate
  • Proactively works to achieve training competency in production operations.  Leads training of other inexperienced associates and is viewed as a system matter expert and qualified trainer for most equipment and procedures.  Assists with the development of training content and helps inexperienced associates understand cGMP documentation practices
  • Group representative with regard to downstream production operations and associated equipment/procedures during audits/inspections or at cross functional team meetings
  • Maintains a clean and orderly production area.  Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.  Ensures effective shift update communications are complete and accurate
  • Assists with daily scheduling of production tasks and coordinates communication with cross functional partners and management regarding production updates and issues affecting the production schedule
  • Participates in investigations of safety or quality issues as necessary.  Authors investigations for deviations related to processing operations ensuring timely and complete documentation
  • Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities
  • Utilizes area expertise to complete projects or assignments of difficult complexity.  Completes specific ownership tasks within the Downstream group with minimal oversight (i.e. maintenance of logbooks, weekly/monthly tasks, etc.)

Required Qualifications:

  • High School Diploma / Associates Degree with exposure to science & math coursework
  • 4+ years of cGMP experience
  • Ability to follow detailed instructions and to maintain accurate records and notes
  • Demonstrated ability to be a successful leader and work effectively in a team environment
  • Organizational and leadership skills with regard to project management
  • Excellent oral and written communication skills
  • Ability to work occasional weekends, holidays or overtime as needed
  • Skills in problem solving and troubleshooting
  • Ability to lift up to 20 Kg
  • Familiarity with MS Office applications (Word, Excel)

Preferred Qualifications:

  • BA/BS degree in a scientific discipline (life sciences / engineering)
  • Previous experience as a Manufacturing Associate within downstream operations
  • Previous experience with single use technology in the biopharmaceutical industry
  • Excellent technical writing skills

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.