Conjugation Manufacturing Specialist
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!
As part of the Conjugation Manufacturing team, the Conjugation Specialist helps to direct and complete production activities related to the conjugation of mAb drug intermediate in a cGMP environment. Works in coordination with other associates and under supervision of the Conjugation Manager. Familiarity in working with Powered Air Purifying Respirator (PAPR) containment systems as well as High Containment Systems (Isolators) and TFF operations is required.
- Guides and performs Conjugation operations safely and compliantly in accordance with OSHA and cGMP guidelines. Conjugation operations include but are not limited to: dispensing and sampling of raw materials, buffer preparation, filtration, Tangential Flow Filtration (TFF) product sampling, and aseptic filling of bulk drug product
- 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. Escalates any issues or abnormalities to management and shift leads, senior associates and/or system matter experts. Participates in resulting troubleshooting activities as necessary
- 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
- Proactively works with senior associates, subject matter experts and management to achieve training competency in production operations
- 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
- Participates in investigations of safety or quality issues as necessary
- Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities
- High School Diploma / Associates Degree with exposure to science & math coursework
- 0-2 years of cGMP experience
- Ability to follow detailed instructions and to maintain accurate records and notes
- Ability to work effectively in a team environment
- Excellent oral and written communication skills
- Ability to work occasional weekends, holidays or overtime as needed
- Ability to lift up to 20 Kg
- Familiarity with MS Office applications (Word, Excel)
- BA/BS degree in a scientific discipline (life sciences / engineering)
- Familiarity with use of PAPR’s and High Containment Systems required
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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.