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Manufacturing Supervisor, Support

Seattle Genetics

This is a Full-time position in Bothell, WA posted December 31, 2020.

Seattle GeneticsManufacturing & Supply Chain ⋅ Bothell, WashingtonDescriptionSummary: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 cleaningPerforms 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 documentationCoaches/mentors and develops manufacturing support associates on performance and working in a cGMP environmentCreates, revises, and reviews SOPs (standard operating procedures) and MBRs (master batch records) as appropriateSuccessfully represents the group with regard to manufacturing support operations and associated equipment/procedures during audits/inspections or at cross functional team meetingsLeads investigations of safety or quality issues as necessary.

Authors investigations for deviations related to processing operations ensuring timely and complete documentationUtilizes 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 activitiesEnsures 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 programHelps inexperienced associates understand cGMP documentation practicesEnsures 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 accuratePerforms and oversees activities related to qualification, commissioning, and decommissioning of equipment and completes documentation for change controls as necessaryLeads 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 scheduleDirects 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 FacilitiesRequired Qualifications:High School Diploma / Associates Degree with exposure to science & math coursework6+ years of cGMP experienceAbility to follow detailed instructions and maintain accurate records and notesKnowledge of downstream mAb production operations and equipmentDemonstrated ability to lead manufacturing operations teams and work effectively in a team environmentExceptional skills working cross functionally with individuals across multiple functional groupsExcellent oral and written communication skillsAbility to work occasional weekends, holidays or overtime as neededSkills in problem solving and troubleshootingDemonstrated organizational and leadership skills with regard to project managementExcellent technical writing skillsAbility to lift up to 20 KgFamiliarity with MS Office applications (Word, Excel)Preferred Qualifications:BA/BS degree in a scientific discipline (life sciences / engineering)Previous supervisory experience desiredPrevious experience with single use technology in the biopharmaceutical industryAs 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#LI-KC1Apply Here: https://www.click2apply.net/MaDQlRcERaEBSkjjsQBRNPI127388327