Seagen

Senior Scientist, Potency Assays

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 responsible for using expert knowledge of scientific principles and concepts in leading the development of in vitro assays to support monoclonal antibody and antibody drug conjugate process development and manufacturing. This individual is expected to serve as a single department point of contact, demonstrate a high level of technical proficiency, scientific creativity, independence, collaborative, and leadership skills. This individual will be responsible for the Potency assay strategy of project teams and for the tactical execution of assay development, qualification, and transfer of Potency assays to QC. This individual will work on drug development problems of diverse scope by leveraging data analysis to identify innovative and practical solutions. This individual will also be responsible for identifying and championing new ideas and technologies that enhance the business process and operations within the Potency function. This individual may lead cross-functional intra-department projects or initiatives. Additional responsibilities may include supervising the activities and providing technical guidance and mentorship to more junior personnel and driving the development of these employees. This individual contributes to regulatory submissions for clinical and licensing applications and to peer-reviewed publications, invention of IP and internal reports. The ideal candidate should be comfortable in working in a fast-paced environment and have a proven track record in the development and implementation of potency assays that are compliant with USP/ICH requirements.

Principal Qualifications:

• Experience to lead large molecule project as analytical or CMC and process development functional lead
• Identification and implementation of new technologies in potency assays to support early- and late-phase product and process development
• Lead and supervise a group of scientist and research associates.
• Regularly meets with, sets clear goals and expectations and provides timely feedback to direct reports
• Applies practical and theory expertise for the development, qualification, implementation and transfer of potency assays (cytotoxicity, binding, Fc effector function, and immunological assays) to support early- and late-phase product and process development
• Leads significant components of Represent the Potency Assay function on various program and cross-functional-functional initiative teams. This role calls for close collaboration with other functional groups within and outside of Process Sciences including Research and Quality
• Independently designs, executes and interprets multiple studies as well as designs experiments carried out by others
• Leverages literature, ICH/regulatory guidance and practical experience to perform work and contribute to the strategy for developing mechanism of action (MOA)-based assays to support program needs and regulatory submissions
• Identification and implementation new technologies and innovative approaches to measure the potency of Seagen’s pipeline molecules that incudes, but is not limited to monoclonal antibodies, multi-domain proteins, and ADCs
• Authors and reviews publications and CMC sections of regulatory submissions (e.g. IND and BLA) and supportive source documents such as technical reports and risk assessments
• Presents at department, project team, and sr. management meetings. May present externally at scientific conferences.
• Increasingly contributes to defining and executing the vision and strategy of the Potency Assay group to achieve business deliverables, aligned with the TOPS dept and the company
• Promote a culture of operational excellence, teamwork, collaboration, inclusivity and diversity

Required Qualifications:

• Excellent understanding of MOA for therapeutic antibodies. Understanding of the regulatory requirements for the safety and efficacy testing of large molecule clinical drugs
• Extensive hands-on experience with the design, development, optimization and qualification of potency assays that reflect the MOA of antibody, ADC and other drug modalities for relative potency determination. Such assays include but are not limited to cytotoxicity assays, binding ELISAs, homogeneous binding assays (AlphaLISA and TR-FRET), flow cytometry, Octet, proliferation, phosphorylation and reporter assay, etc.
• Experience in the use of live cell imaging systems and high-throughput liquid-handling systems is strongly desired
• Experience with current statistical approaches to evaluating potency data e.g. parallel line analysis, determination of relative potency, USP chapters on Bioassay, and design of experiments (DOE). Extensive experience in partnering with internal and external functions to transfer and implement potency assays
• Highly competent in common software and data analysis packages e.g. SoftMax Pro, JMP, PLA software, GraphPad Prism, Microsoft Office Tools
• Leverage external networks to stay current on industry best practices and emerging technologies in potency assay development and support improvements on existing capabilities
• Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate complex data and the impact to program and regulatory strategy
• Proven experience in supporting regulatory submissions (INDs, BLAs, IMPDs, MAAs)
• Demonstrated experience managing and mentoring direct reports
• Support the creation and implementation of best practice guidelines, digitals tools and infrastructure
• Strong written and verbal communication skills
• Strong interpersonal skills and the ability to work in a multi-disciplinary team environment

Preferred Qualifications:

• B.S. and 14+ years; M.S. and 11+ years; Ph.D. and 3+ years; CMC and/or industry experience are highly desirable

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 $133,000 to $171,600 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: 12/16/2022