Seagen

Remote Scientist CMC Statistics

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 Scientist, CMC Statistics role is part of the CMC Statistics team of the Data Science department. With the team, the role is responsible for assisting scientists across the Technical Operations and Process Sciences (TOPS) division with performing statistical analyses, designing experiments, generating technical reports, and maintaining code associated with these tasks. This role will involve extensive collaboration with stakeholders within the Data Science team, as well as across Seagen’s TOPS, Manufacturing, Quality, and Product Supply teams. The successful candidate must be a high-performing team player with strong communication skills who thrives in a fast-paced environment.

Responsibilities:

• Provide statistical expertise to multiple CMC areas, including process development (process characterization, optimization, robustness, and tech transfer/comparability), and analytical development (including analytical development, qualification, validation, robustness and method transfer/reproducibility)
• Provide statistical expertise to support global quality including stability studies and shelf life/expiration, Product Quality Reviews
• Provide statistical analysis support to global manufacturing for continued process verification, deviations and investigations
• Propose experimental design and analysis strategies, perform statistical analyses, and collaborate to ensure the statistical integrity of data in development and GMP manufacturing
• Support regulatory submissions and investigations
• Proactively develop and sustain strategic partnerships with collaborators and promote statistical thinking in decision making
• Ensure sound data management practices
• Keep current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities

Qualifications:

• PhD in Statistics or related discipline with 0+ years of relevant experience; MS degree in Statistics or related discipline with 5+ years of relevant experience.
• Proficiency with Statistical Software tools SAS, R, JMP, SIMCA, or similar statistical software.
• Experience with Statistical methods such as Design of Experiments (DOE), linear and nonlinear regression modeling, variance component analysis, multivariate analysis, process capability and control and/or other aspects of engineering statistics.
• Strong verbal, written, and presentation skills.

Preferred:

• Experience in Biopharmaceutical development and manufacturing
• Knowledge of FDA regulations and other industry and regulatory related guidance
• Experience in combining statistical methodologies with machine learning techniques in the execution of far-reaching data solutions unique to the CMC pharmaceutical industry

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 $110,000 to $142,000 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: 03/10/2023