Manufacturing Supervisor, Support

Product Supply Operations Bothell, Washington


Description

Summary:

As part of the Manufacturing Support team, the Manufacturing Support Supervisor oversees a team of Manufacturing Support Associates responsible for production support activities in a cGMP environment.  The Supervisor reports to the Head of Manufacturing, or Head of Upstream or Downstream Manufacturing and works collectively with other Supervisors, Specialists and senior associates to support production activities.

Principal Responsibilities:

  • Performs oversight of manufacturing support activities ensuring they are executed safely and compliantly in accordance with OSHA and cGMP guidelines. Supervises and performs, as necessary, operations including but not limited to; dispensing and sampling of raw materials, buffer preparation, cleaning of small equipment and parts, staging of filter and tubing assemblies for autoclaving, cleanroom gowning management, and GMP facility cleaning
  • Performs review of process documentation including batch records, forms and logbooks ensuring alignment with good cGMP and data integrity practices. Works collaboratively with Manufacturing and Quality Assurance personnel to address any deficiencies with process documentation
  • Coaches/mentors and develops manufacturing support associates on performance and working in a cGMP environment
  • Creates, revises, and reviews SOPs (standard operating procedures) and MBRs (master batch records) as appropriate
  • Successfully represents the group with regard to manufacturing support operations and associated equipment/procedures during audits/inspections or at cross functional team meetings
  • Leads investigations of safety or quality issues as necessary. Authors investigations for deviations related to processing operations ensuring timely and complete documentation
  • Utilizes experience to articulate any production issues or abnormalities to management and other cross functional groups. Provides insight and recommendations to address production issues and oversees the execution of any non-routine or troubleshooting activities
  • Ensures accountability of self and direct reports to achieve and maintain 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
  • Ensures manufacturing support team 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 and oversees 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
  • Directs 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 maintain accurate records and notes
  • Knowledge of downstream mAb production operations and equipment
  • Demonstrated ability to lead manufacturing operations teams 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 supervisory experience desired
  • Previous experience with single use technology in the biopharmaceutical industry

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com. 

Seagen 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. 

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