Job Detail

Description

Summary: 

The MSAT Sr Scientist/Engineer is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of Seagen small molecule API’s, 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 technology transfers to or between contract manufacturers.  

The MSAT Sr Scientist/Engineer supports 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. 

Principal Responsibilities: 

• Support for small molecule API (drug substance) 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 


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


• Act as the Technical Lead in Technology Transfers of processes into manufacturing facilities 


• 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 and technical advisor 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. 


• Participate in 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 


• Collaborate with Development and manufacturing sites for know-how transfers. 


• Initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance. 

 Qualifications: 

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


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


• 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 Seagen. 


• 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) 

#LI-KM1