Manufacturing Specialist Cell Culture Launchpad

Description

Position at Seagen

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 Manufacturing Specialist, Cell Culture Drug Substance, 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 :

• Role will primarily be focused on technical writing and change management, including deviation investigations, change controls, corrective/preventative actions, and development of SOP's and Master Batch Records
• Authors/reviews/improves manufacturing documents, technical reports, and validation documents as needed
• Performs activities related to qualification, commissioning, and decommissioning of equipment and completes documentation for change controls as necessary
• Your role on the manufacturing floor is to provide insight and recommendations when needed to address production issues or assist with the execution of any non-routine or troubleshooting activities
• When necessary, performs cell culture operations safely and compliantly in accordance with OSHA and cGMP guidelines. Subject Matter Expert on all operations related to cell culture processing
• Help evaluate, develop, and implement new manufacturing technologies
• Successfully represents the group regarding cell culture production operations and associated equipment/procedures during audits/inspections or at cross functional team meetings
• Proactively works to achieve training competency in production operations. Develops, reviews, and modifies training content as necessary to build and maintain a comprehensive training program
• 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
• 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. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, MSAT and Facilities

Required Qualifications:

• Bachelor's degree preferably in Life Sciences or Engineering, or High school diploma/associate degree with equivalent cGMP experience
• 5+ years of experience operating in a cGMP biopharmaceutical manufacturing facility and knowledge of cGMP regulations
• 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
• Experienced in large-scale cell culture operations and associated equipment
• Adaptable to a fast-paced dynamic business environment
• Excellent oral and written communication skills, both written and verbal, and ability to prioritize competing tasks
• Ability to work cross functionally and cooperate across organization to solve problems and manage process improvements
• Experience preparing data for reports and presentations and experience in technical report writing
• Familiarity with MS Office applications (Word, Excel)

Preferred Qualifications:

• BA/BS degree in a scientific discipline (life sciences / engineering)
• Previous leadership experience desired

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 $89,000 to $115,500 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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