Seagen

Principal Scientist Small Molecule Process Development

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 Principal Scientist uses expert knowledge of scientific principles and concepts to solve complex drug development problems in creative and effective ways. They serve as technical advisor to sr. management and build relationship between functional areas or external partners. They advise on patent or CMC regulatory strategies and develop approaches to resolve regulatory issues within CMC team. They demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought to support and influence teams. They establish a long-term vision of skill sets for functional area and prioritize/allocate effort in team. They may supervise staff and would be responsible for driving the development of those employees. They develop an external presence as technical leader in the field by authoring journal articles, presenting posters at leading external scientific meetings, or as invited speaker.

Principal Responsibilities:

• 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
• Applies the latest technologies in both organic and analytical chemistry to develop and interrogate chemical processes while capturing critical data for the determination of reaction parameters that contribute to process performance and scale up
• Uses established principles of chemical process development to design efficient processes with facile unit operations
• 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 builds the 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
• Serves as technical advisor to senior management on risks to project
• Provides scientific leadership in evaluation of experimental results and analytical data for one or more programs
• Leads Drug-Linker (DL)/API teams and aligns efforts with CDMOs to achieve chemistry and scale-up related project goals
• Contributes to the design and integration of cross-functional research efforts within both Research and Technical Operations (TOPS)
• Be responsible for the development of robust chemical processes with scientific excellence and rigor
• Clearly defines project responsibilities and timelines; drives alignment of short- and long-term program needs with DL/API deliverables
• Active external presence in scientific community: collaborates with academia and participates in consortia and conferences

Qualifications:

• Maintains a rigorous understanding of complex mechanistic theory and broadly shares expertise. Possess a high level of expertise in organic chemistry, reaction mechanisms, and knowledgeable of current advances in the field
• Proven track record in developing synthetic routes and optimizing chemical processes for complex target molecules
• Proactive in driving compliance with cGMP standards
• Experienced in resolving cross-functional CMC issues in small molecule development
• Demonstrates leadership in strategic project planning: manufacture sourcing strategies, timeline planning, DL/API supplies
• Fosters a culture of safety among team members
• Meaningfully contributes to increasing the capabilities of Process Chemistry by leading and/or contributing on initiatives
• Principal scientist level requires broad subject matter expertise in multiple technical areas of formulation or DP process development, working knowledge of both. Extensive experience required in supporting regulatory submissions and a thorough understanding of ICH and Regulatory Guidance
• Excellent oral and written communication skills, ability to lead cross-functional development teams, and capability to provide strategic contributions

Education:

• Degree in Organic Chemistry/Pharmaceutical Chemistry
• Principal – B.S. with 17+ years or M.S. with 14+ years or Ph.D. with 6+ years of industrial experience

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 $149,000 to $192,500 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: 12/09/2022