Global Product Steward (Biologics)
The MSAT Technical Product Steward is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support for manufacturing Seagen products manufactured internally or at contract manufacturing organizations (CMO’s). This position has responsibility for the technical oversight of Seagen’s global supply network and consequently includes remote leadership and work across different time zones. The incumbent is an expert and has extensive knowledge of Biologics Drug Product manufacturing and plays a technical leadership and coordinating role for the end-to-end manufacturing process working in close collaboration with MSAT experts. This role partners with the Internal/External Manufacturing Manager and the Product Quality Leader ensuring the robustness of the manufacturing process, product quality and continuity of supply. The incumbent leverages knowledge across the organization and collaborates with peers from Development functions to ensure the robustness of new manufacturing processes. The Technical Product Steward is accountable for technology transfers to or between contract manufacturers. The Technical Product Steward works in close cooperation of the MSAT Validation Director ensuring robust the process validation and compliant GMP manufacturing of Biologics Products. The incumbent provides technical and scientific leadership as subject matter expert (SME) relating to manufacturing processes, change control, scale-down/up studies, technology implementation projects and process optimization. The incumbent coaches and shares expertise and knowledge across Technical Operations.
- Works in collaboration with the Strategic Product Supply Lead (SPSL) to develop and execute Product Supply manufacturing strategies
- Provides technical oversight for the end-to-end manufacturing activities for clinical and commercial manufacturing of Biologics Drug Substance and Drug Product (liquid and lyophilized in vials, cartridges, and syringes) at CMO’s and internally. Ensuring that manufacturing process are and remain aligned across manufacturing sites/CMOs
- Partners with the Internal/External Manufacturing Manager and the Product Quality Leader to ensure the robustness of the manufacturing process, product quality and continuity of supply
- Provides overall technical leadership for the end to end (API to Packed Product) manufacturing process for Biologics working in close collaboration with MSAT SMEs
- Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process optimization
- Is accountable for the Technology Transfers into manufacturing facilities (internal or external)
- Working in close cooperation with the MSAT Validation Director ensures that DS and DP successfully transitions through the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification)
- Partners with, and leverages expertise from, the global Seagen organization to apply appropriate tools and methodologies to ensure manufacturing processes are robust and scientifically sound leading to a predictable and highly consistent performance (e.g., modeling tools to ensure that scale-down/up activities are controlled and understood and that characterization of product and processes is carried out and knowledge captured)
- Providing guidance for root cause investigations of process related deviations in a timely, comprehensive and conclusive manner
- Leads the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements
- Acting as shop-floor support (person-in-plant) during tech transfer, validation studies and commercial manufacturing
- Providing guidance for comprehensive facility fit assessments and gap analysis for the relevant part of the GMP manufacturing
- Working cross-functionally supporting Development and Manufacturing as well as CMO’s in order to prepare User Requirement Specifications (URS) of novel process technologies and facility expansions/modifications to maintain state-of-the-art production meeting business needs
- Interfacing with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes. Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance
- Advises on Scientific and Business developments (including Technologies, Processes, Products, Input Materials, Regulations etc.). Supports Due Diligence activities, CMO selections etc.
- Coaches and shares knowledge across Technical Operations
- Extensive scientific and technical experience within relevant development and/or manufacturing technologies and unit operations relating to Biologics manufacturing including characterization/analytical techniques. Experience with small and commercial scale equipment utilized in cGMP manufacturing facilities (including clinical manufacturing).
- Experience of end to end (API to Packed Product) technical leadership
- Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
- The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
- Experience working with Contract Manufacturing Organizations is required
- Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seattle Genetics
- Able to operate at both strategic and detailed technical levels
- The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally
- Strong communication skills and computer literacy are essential
- Fluency in spoken and written English is mandatory
- Experience with innovation and operational excellence is desirable
- A good understanding of statistical analysis and continuous process verification is desirable
- Masters’ degree in biotechnology, chemical engineering, or another relevant life-science discipline with a minimum of 15 years of industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and/or process optimization. Alternatively, a PhD degree with minimum 12 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 Seattle Genetics, 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.