Manufacturing Specialist Downstream

Manufacturing & Supply Chain Bothell, Washington


Description

Summary: 

As part of the Downstream Manufacturing team, the Manufacturing Specialist completes production activities related to downstream purification of mAb drug intermediate and drug product in a cGMP environment.  The Specialist reports to the Downstream Manufacturing Manager and works collectively with other Supervisors, Specialists and senior associates to lead production activities and projects related to Downstream operations.

Principal Responsibilities:

  • Performs downstream operations safely and compliantly in accordance with OSHA and cGMP guidelines.  Leads operations including but 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 leading the execution of any non-routine or troubleshooting activities.  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
  • Successfully represents the group with regard to downstream production operations and associated equipment/procedures during audits/inspections or at cross functional team meetings
  • Participates in investigations of safety or quality issues as necessary.  Authors investigations for deviations related to processing operations ensuring timely and complete documentation
  • Proactively works to achieve training competency in production operations.  Leads training of other inexperienced associates and is a system matter expert and qualified trainer for relevant equipment and procedures.  Develops, reviews, and modifies training content as necessary to build and maintain a comprehensive training program. Helps inexperienced associates understand cGMP documentation practices
  • 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
  • Performs activities related to qualification, commissioning, and decommissioning of equipment and completes documentation for change controls as necessary
  • Leads or assists with scheduling and execution of production tasks including campaign startup and product changeover.  Coordinates communication with cross functional partners and management regarding production updates and issues affecting the production schedule
  • Participates and supports a culture of continuous improvement utilizing area expertise to help implement best practices promoting quality risk management and operational excellence principles.  Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities

Required Qualifications:

  • High School Diploma / Associates Degree with exposure to science & math coursework
  • 6+ 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
  • Exceptional skills working cross functionally with individuals across multiple functional groups
  • Excellent oral and written communication skills
  • Ability to work occasional weekends, holidays or overtime as needed
  • Skills in problem solving and troubleshooting
  • Demonstrated organizational and leadership skills with regard to project management
  • Excellent technical writing skills
  • 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 or Specialist within downstream operations
  • Previous experience with single use technology in the biopharmaceutical industry

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.