Seagen

Senior Scientist Quality Control Lead

Technical Operations & Process Sciences - Bothell, Washington

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

Quality Control Lead (QCL), Senior Scientist, is a seasoned QC expert in the Development QC group with extensive knowledge and experience with overall GMP analytical processes and requirements through development and product registration. This individual contributor manages the partnering QC analytical functions and aspects of biopharmaceuticals to ensure that internal and external testing strategies comply with cGMP, regulatory expectations, and corporate objectives. The individual leads and manages the development of the analytical testing strategy for all GMP-QC related activities for newly developed clinical materials from early clinical development through initial registration until handoff to the Commercial QC group.

Principal Responsibilities:

• Serve as the single point of contact in QC for assigned development program(s)
• Collaboration and interaction with internal cross functional teams and business partners
• Be responsible for QC strategies pertaining to development material, including material testing, GMP and/or IPC manufacturing control strategy, specification setting and implementation, material stability, reference selection & certification, and QC disposition
• Oversee QC deliverables to support CMC activities
• Contribute to the design or improvement of analytical methods for a robust routine use in a GMP setting, establishing the GMP testing strategy and evaluating criteria for obtaining results independently
• Author assigned CMC sections for new and amended IND/IMPDs and license applications (BLA/NDA/MAA)
• Author, review and approve technical reports
• Lead and support product related investigations and technical reports in response to OOS/OOE/OOT as an analytical and QC Subject Matter expert (SME)
• Collaborate with Global Quality, development functions (i.e. Analytical Sciences, Pharmaceutical Sciences, Supply Chain, etc.), stakeholders, QC customers, and/or partners to achieve product development goals
• Represent Development QC on the Process Development team, Tech Transfer team, and/or other sub-teams internally and externally
• Represent QC in intra-department project/initiative in support of program and company goals
• Exercise judgment within generally defined practices and policies to obtain solutions for establishing the analytical testing strategy for Seagen products

Required Qualifications:

• Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in biology, biochemistry or any related technical discipline.
• A minimum of 10 years of relevant experience in pharmaceutical/biological drug product development, analytical chemistry, and/or quality control in a regulated biotechnology pharmaceutical company with progressive levels of responsibility are required (recommended 12+ years overall relevant experience).
• Expert knowledge of scientific principles and technical aspects of mAb and ADC or analytical and control strategies.
• Experience designing and monitoring studies or experiments for comprehensive product or material evaluation, respectively.
• Widely recognized expert with excellent analytical mindset and technical skills such as UPLC/HPLC, SE-HPLC, RP-HPLC, CE-SDS, icIEF, etc.
• Strong project management skills and experience managing multiple projects at the same time is essential.
• Possess strong data interpretation and method troubleshooting skills and exercises sound scientific judgement; highly capable of utilizing inductive and deductive reasoning to drive decisions and recommendations.
• Strong time management skills with attention to detail and desire to achieve team and individual goals.
• Good communication skills to lead a team and influence other leaders or cross-functional team members.
• Experience with regulatory guidance and requirements (ICH, CFR, general guidance), regulatory submission such as IND, IMPD, BLA or NDA, etc.
• Demonstration of successful leadership in a matrix environment to deliver strategic vision.
• Experience with a phase-appropriate GMP approach to QC activities, such as analytical validation and transfer.

• Hands-on QC Lead experience (or equivalent) with biologics (including ADC) or small molecules, aseptic products (both liquid and lyophilized forms)

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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/27/2022