Job Detail

Description

Summary:

The MSAT Sr./Engineer is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of Seattle Genetics small molecule products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The Incumbent collaborates with peers from Development functions to ensure a high degree of manufacturability of processes being developed and will contribute to or lead technology transfers to or between contract manufacturers. The MSAT Sr. Scientist/Engineer will support process validation and GMP manufacturing including person-in-plant presence and trouble-shooting activities at CMO’s, working closely with QA and QC. 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.

Responsibilities:

• Supporting small molecule (drug substance and drug product) manufacturing activities for clinical and commercial manufacturing internally or at CMO’s


• 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


• Acts as Tech Transfer lead for transfer of processes into manufacturing facilities


• Support the DS/API throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification)


• Partnering with other functions to apply e.g. modelling tools ensuring that scale-down/up and characterization of manufacturing processes is robust and scientifically sound leading to a predictable and highly consistent performance and a well characterized process


• 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 person-in-plant during tech transfer, validation studies and commercial manufacturing


• Develop, optimize, and review Master Batch Records and Batch Records during development, clinical supply and transfer to commercial supply


• Providing guidance for comprehensive facility fit assessments and gap analysis for the relevant part of the GMP manufacturing


• 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

Qualifications:

• Demonstrated knowledge and proficiency in the synthesis and scale-up of small molecule compounds (multi-step synthesis, route selection, chromatography, crystallisation, solid form etc.) is required


• Experience with GMP Drug Product manufacturing for oral dosage forms (blending, compaction, tableting, film-coating, etc.) is desired


• Strong scientific and technical experience within relevant manufacturing process technologies and unit operations. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities


• 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 desirable


• Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seattle Genetics


• 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


• Experience with innovation and operational excellence is desirable


• A good understanding of statistical analysis and continuous process verification is desirable


• Education:


• Bachelor’s degree in Chemistry/Chemical Engineering or related discipline with a minimum of 8 years relevant industrial experience


• Alternatively, M.S. or Ph.D. in Organic Chemistry, Analytical Chemistry, Chemical Engineering or related discipline (M.S. and 6 years or Ph.D. with 4 years of industrial experience)

Education:

• Bachelor’s degree in Chemistry/Chemical Engineering or related discipline with a minimum of 8 years relevant industrial experience


• Alternatively, M.S. or Ph.D. in Organic Chemistry, Analytical Chemistry, Chemical Engineering or related discipline (M.S. and 6 years or Ph.D. with 4 years of industrial experience)