Seagen

Director Formulation and Drug Product Development

Description

Summary

This position will focus on formulation development and characterization of Seattle Genetics' (SGEN) antibody and antibody-drug conjugate (ADC) drug products. The successful candidate will work closely with Bioprocess Development, Analytical Sciences, and Quality Control. The successful candidate will also provide formulation and process characterization to support regulatory filings.

Requirements:

• Drives vision and purpose for the functional area of formulation and drug product sciences (DP)
• Provide strategic oversight and leadership on biologic product development activities including formulation, DP process development, technology transfer, and process characterization
• Lead a high-performing team for pre-formulation, formulation, and DP process development, and continue improve in-house expertise and laboratory capacity
• Leading the effort in developing stable liquid and lyophilized formulations for antibodies and antibody drug conjugates (ADCs). Oversee multiple development projects including early phase and later phase programs
• Provide strategic contributions to department operation and product development. Support senior leaders on continuous growth of the department, such as incorporate new technologies, improve efficiency, and establish best practices
• Provide strategic contribution to the strategy, practice, and operations in CMC development. Lead or participate cross-functional taskforces and initiatives
• Review or author relevant CMC sections of regulatory submissions.
• Serve as SME or provide strategy guidance for key regulatory interactions
• Support technical transfer and manufacturing activities at fill finish CMOs. Cultivate excellent working relationship with internal and external partners to deliver successful manufacturing processes
• Collaborate effectively with other groups, including Purification, Conjugation, Analytical, Quality, Regulatory, Clinical, and Manufacturing and Supply Chain Management
• Participate or support budgeting process
• Recruit, motivate and develop staff, encourage personal growth and operational excellence

Qualifications:

• S and 15+, or Ph.D with 10+ years of industrial experience in Pharmaceutical Development
• 6 + years supervisory or leadership experience

Education:

• M.S. or Ph.D. in Pharmaceutical Sciences, Biochemistry, Biological Sciences or related discipline

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/25/2020