Seagen

Director Global Technical Development

Technical Operations & Process Sciences - Bothell, United States

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

In this capacity the incumbent will provide strategic leadership to one or more CMC programs teams and is accountable for all phases of (Phase I-IV) development activities, for small molecules, drug linkers and biologics. They are accountable for defining best practices and guiding CMC team for timely delivery of investigational product for first in human, on-going clinical trials, and transfer of well characterized, robust, analytical methods and manufacturing processes to the Commercial Product Supply organization. As a member of the Strategic Portfolio Management Office team and in the spirit of learning and continuous improvement they need to advance functional and organizational excellence.

Responsibilities:

• Lead cross-functional CMC Team(s) to develop, adapt and drive an integrated CMC development strategy for all stages of programs, taking into account corporate priorities and objectives.
• Represent Technical development on Global Product Team, and jointly establish strategy and tactics for development and commercialization of innovative drugs. Technical Development includes drug substance, drug product, technical transfer, clinical supplies and supporting functions.
• Serve as the primary CMC point of contact and product representative on executive management and governance committees.
• Work closely to influence, advise and coordinate strategic and operational efforts across all key CMC functions, including Process Sciences, Analytical Development, Manufacturing, Quality and CMC-Regulatory to ensure strategic alignment and seamless execution.
• Work closely with partners on co-development programs, to develop and execute a joint global CMC strategy which delivers on the shared vision for the product while successfully.
delivering company-specific expectations
• Drive team objective setting, prioritization and ensure adherence to plan and strategy.
• Drive risk management, issue identification, resolution, and contingency planning.
• Identify opportunities for improvement, product lifecycle support, and lead development of action plans.
• Create a positive team environment which instils trust, encourages disconfirming information, and enables clear transparent communications, to facilitate alignment around the overall goal/vision for the product.
• Accountable for developing Technical Operations strategy based on overall program and executing it per the agreed upon budget, timeline using Program Management principles.
• Stay abreast of changes in the regulatory standards and expectations, evolving business needs, and scientific advancements to determine impacts on the product’s CMC package and the need for adjustments.
• Advance functional and organizational excellence as a member of the GTD (including CMC) Strategy & Program Management leadership team.

Qualifications:

• Director: 10+ years of biopharmaceutical drug development experience and 5+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership).
• Associate Director: 5-10+ years of biopharmaceutical drug development experience and 2-5+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership).
• Ability to effectively handle ambiguity and uncertainty.
• Proven ability to build trustful and effective relationships.
• Able to think strategically and translate strategies into actionable plans.
• Strong verbal and written communication skills and the ability to influence at all levels.

Education:

• Master’s or Doctorate degree in a scientific, or engineering discipline. PMP certification is a plus.

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: 10/21/2022