Seagen
Senior Manager Quality Control - 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!
Position Summary:
Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).
The Sr. Manager of QC Chemistry will oversee raw material, in-process, release, and stability testing for Seagen’s new biologic drug substance and drug product manufacturing facility in Everett, Washington. This position leads a team of Scientist and Associate level staff in a high-throughput GMP laboratory. This position also provides technical expertise on QC quality systems, including technology transfer, equipment onboarding, laboratory control procedures, data integrity, and investigations. The Launchpad QC laboratory will support drug substance and sterile drug product manufacturing for both clinical and commercial products and will work closely with other Seagen sites to ensure the safety and compliance of our products and manufacturing operations.
This position reports to the Director of Quality Control – Launchpad.
Principal Responsibilities:
- Manage the day-to-day operations of a high throughput laboratory performing compendial and product specific test methods, including HPLC, CE-SDS, icIEF, ELISA, SoloVPE, and other analytical techniques
- Support the commissioning and qualification of large-scale biologic drug substance and drug product manufacturing operations
- Recruit, hire, train, and mentor outstanding QC laboratory staff
- Author, review, and approve procedures, risk assessments, protocols, reports, and other deliverables supporting GMP operations
- Work closely with MSAT, QA, and Supply Chain personnel to develop raw material sampling, testing, and qualification workflows
- Oversee the execution of analytical method transfer and validation studies, compendial verifications, qualification of critical reagents, and related functions
- Ensure completion of change controls, investigations, and CAPA within agreed upon timelines. Act as SME on investigations and changes related to the sampling and testing of raw materials, process intermediates, bulk drug substance, and drug product
- Manage on-call and shift-based teams, as necessary, to provide support for operations during evenings and weekends
- Ensure that the QC Chemistry laboratory maintains compliance with Seagen and health authority requirements and aligns practices and technologies with other Seagen operations
- Identify and implement opportunities for continuous improvement in sampling, testing, data analysis, and method validation workflows
Expected Qualifications:
- 12+ years relevant GMP/QC experience
- Bachelor's or Master’s degree in chemistry, biochemistry, or a related discipline
- 5+ years of experience supervising / managing direct reports
- Extensive knowledge of compendial and regulatory requirements for GMP QC laboratories and analytical methods
- Technical expertise in QC biologics and raw materials testing, including wet chemistry, HPLC / UPLC, ELISA, and capillary electrophoresis-based methods
- Experiencing managing or executing method transfer and validation studies, and compendial method verification studies
- Experience purchasing, commissioning and qualifying QC equipment and software systems
- Knowledge of data integrity and electronic records requirements with specific experience implementing ALCOA+ and 21CFR Part 11 compliant practices
- Demonstrated ability to work productively with Manufacturing, QA, Analytical Sciences, and other stakeholders to develop robust workflows, troubleshoot analytical issues, and support investigations and change controls
- Experience using common laboratory software such as Empower, LIMS, and ELN systems
- Experience supporting internal and health authority audits and inspections
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 $134,000 - $174,000 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 03/31/2023
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