Seagen

Supervisor Manufacturing Drug Substance Solution Prep - Launchpad

Technical Operations & Process Sciences - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

Seagen is seeking a highly motivated Manager, Manufacturing Solution Preparation, that desires an opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The initial focus of this position will be to actively participate and contribute to the design, build, and operational startup of Seagen’s new cGMP manufacturing facility, “Project Launch Pad” is being built in Everett, Washington, just North of Seattle. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

Principal Responsibilities:

• Manage the execution of all solution prep manufacturing operations including pre-production area checks, assembly/cleaning/sterilization of equipment, preparation of buffer and cell culture solutions
• Supervise micro cleaning of GMP Drug Substance, Drug Product, and Warehouse areas
• Establishment of GMP documentation (SOPs), training curriculum for cleaning personnel
• Ensure oversight of daily, weekly, and monthly cleaning meet environmental monitoring criteria
• Partner with the Compliance and Quality Operations groups to ensure alignment with quality directives and internal manufacturing best practices and improvements
• Participate directly in internal, external, and global health authority audits/inspections
• Develop and maintain the operations schedule in conjunction with the area management, supervisors, and planning team
• Assist in the daily coordination of workload among shifts, working directly with other managers/supervisors
• Manage equipment/process investigations
• Proficient in Quality Systems, including investigations, change control, and corrective/preventative actions
• Authoring/reviewing/improving manufacturing documents, technical reports, and validation documents as needed
• Developing and demonstrating proficiency in process automation and business quality systems and software
• Ensure corporate and site Quality KPI targets are achieved. Partner with Manufacturing Compliance and Quality to ensure proper adherence to Quality Systems requirements
• Maintain production area are in a state of audit-readiness and staff are quality and compliance minded
• Actively develop less experienced staff through the assignment of development opportunities, coaching, mentoring, and administration of rewards and recognition
• Hire, integrate and develop high quality talent capable of delivering against the department’s goals and objectives
• Ensure all staff training is up to date and compliant

Required Qualifications:

• Bachelor’s degree preferably in Life Sciences or Engineering, or High school diploma/associate degree with equivalent cGMP experience
• 5+ years of relevant GMP biopharmaceutical industry and/or micro cleaning of GMP facilities
• Strong knowledge in cGMPs for the manufacturing of biological products
• Adaptable to a fast-paced dynamic business environment
• Experienced in large-scale solution prep operations utilizing disposable/single-use technology is preferable
• Good organizational and communication skills, both written and verbal, and the ability to prioritize competing tasks
• Engages in and supports a culture of continual improvement; is attentive and approachable
• Excellent interpersonal skills with the ability to work well with others in a dynamic and highly collaborative environment
• Proven ability to work well with cross-functional teams supporting biopharmaceutical manufacturing

Preferred Qualifications:

• Bachelor’s degree preferably in Life Sciences or Engineering, or High school diploma/associate degree with equivalent cGMP experience Working knowledge of ADC mAb conjugation processes
• Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company
• A minimum of 5+ years of experience operating in a cGMP biopharmaceutical manufacturing facility and knowledge of cGMP regulations
• 1-2+ years of leadership experience
• Willing and able to work reliably on a flexible schedule, Monday-Friday, and some weekends, to meet production schedule
• Ability to follow detailed instructions and maintain accurate records as well as possessing skills in troubleshooting and problem solving Understanding of process automation (e.g., DeltaV) and MES systems
• Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
• Promotes a highly collaborative team focused environment and demonstrates interpersonal skills to effectively lead and coordinate manufacturing operations
• Adaptable to a fast-paced dynamic business environment
• Excellent oral and written communication skills, both written and verbal, and ability to prioritize competing tasks
• Applies knowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technology advancement

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.

The hiring pay range for this position is $99,000 to $127,600 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/17/2023