Seagen
Principal Scientist Conjugation
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 Seagen Conjugation Process Development group is seeking an experienced Principal Scientist to lead antibody-drug conjugate (ADC) process development projects ranging from early-phase clinical molecules through late-stage or commercial products. The Principal Scientist will use their expert knowledge of scientific principles and concepts to solve complex drug development problems in creative and effective ways. They will identify and champion new ideas and technologies that enhance business processes within the Conjugation Process Development group. They may supervise the activities of more junior personnel and would be responsible for driving the development of those employees. They may lead intra-department projects or initiatives involving cross-functional contributors. They will contribute toward peer reviewed publications, invention of IP, internal reports, and/or regulatory filings.
Principal Responsibilities:
- Able to oversee multiple development projects, including early and late-stage programs.
- Leads process characterization studies, risk assessment, and control strategy development for late-stage process development.
- Supports validation activities.
- Leverages scientific and technical experience in initiating new projects or bringing new scientific technologies that address important business needs. Pursues new areas of process and assay development, and manufacturing.
- Establishes business practices that advance drug development and manufacturing Develops approaches that allow resolution of discrepancies and regulatory issues.
- Leads inter-departmental teams and represents department in senior management meetings.
- Guides development efforts to comply with regulatory expectations. May defend position in front of regulatory agencies.
- Thorough understanding of ICH and Regulatory Guidance and applies knowledge to drive regulatory strategies for development and CMC documents.
- Creates a long-term vision of the skillsets needed for the group and build group towards that vision (either recruit or train). Motivates and supports the career development and technical growth of direct reports.
- Authors technical summaries, white papers, or publications (internal or external) which support department’s policies and goals.
- May present at national/international forums or chair and/or help organize external meetings in area of expertise.
- Technical advisor to senior management on risks to project. May serve as functional area lead for clinical programs/inter-departmental initiatives.
Required Qualifications:
- Senior Scientist: B.S. and 14+ years; M.S. and 11+ years; Ph.D. and 3+ years of industry experience
- Principal Scientist: B.S. and 17+ years; M.S. and 14+ years; Ph.D. and 5+ years of industry experience
- Degree in chemistry, biochemistry, chemical engineering, or related field
- Deep knowledge of bioconjugation and/or protein purification processes
- Experience with GMP manufacturing of biologics and technology transfer to manufacturing sites
- Experience with regulatory submission process for biopharmaceuticals
- Good understanding of analytical ADC or protein characterization (HPLC, IEF, CE-SDS)
Preferred Qualifications:
- Experience with ADC process development
- Direct experience with antibody or protein conjugation
- Proficiency with tangential flow filtration
- Experience with late-stage development
- Familiarity with CMC team function
- Strong knowledge of statistical software such as JMP
- Experience with programming languages such as Python, R, or SQL
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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 07/01/2022
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