Seagen

Senior Scientist Quality Control Lead

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:

The Sr. Scientist, Quality Control Lead (QCL), is a QC expert within the QC group with a good understanding of GMP analytical processes and requirements through development and product registration. This individual contributor manages the QC analytical activities and aspects of small molecules to ensure that testing strategy complies 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 commercialization.

Principal Responsibilities:

• Serve as the single point of contact in QC for assigned program(s).
• Collaboration and interaction with internal and external cross functional teams.
• Responsible for oversight of small molecule reference standard inventory for multiple programs, management of reference standards qualification/requalification, and coordinating reference standards shipment to testing sites.
• Be responsible for QC strategies pertaining to assigned program(s), 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 design or improve analytical methods for robust routine use under GMP, 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 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 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 and obtains solutions for establishing the analytical testing strategy for our various materials

Required Qualifications:

• Bachelor’s degree in life science (post-graduate degree in a related field is a plus) in chemistry, biology, biochemistry or any related technical discipline
• A minimum of 10 years 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.
• Expert knowledge of scientific principles and technical expertise with small molecule or linker analytical analysis and control strategies, able to design and evaluate the design of study/experiment.
• Have good analytical mindset and technical skills such as UPLC/HPLC, GC, FTIR, Mass Spec, NMR, etc.
• Good project management skills and experience managing multiple projects at the same time is essential.
• Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement.
• Good 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.
• Familiarity with regulatory guidance and requirements (ICH, CFR, general guidance), regulatory submission such as IND, IMPD, BLA or NDA, etc.
• Familiarity with a phase appropriate GMP approach to QC activities, such as analytical validation and transfer.

Preferred Qualifications:

• Hands-on QC Lead experience (or equivalent) with small molecules/Linkers
• Demonstration of successful leadership in a matrix environment to deliver strategic vision

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 $172,000 to $152,000 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.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/17/2023