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 all Seattle Genetics products, whether manufactured internally or at contract manufacturing organizations (CMO’s).
The Incumbent is an expert on small molecule Drug Product manufacturing, collaborates with peers from Development functions to ensure a high degree of manufacturability of the 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 incl. shop-floor 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.
Supporting manufacturing activities for clinical and commercial manufacturing of small molecule Drug Product (oral solid dose) 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
Occasionally acts as Tech Transfer lead for transfer of processes into manufacturing facilities
Partnering with other functions to apply e.g. modeling 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 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
Strong scientific and technical experience within relevant development and / or manufacturing technologies and unit operations relating to Oral Solid Dose (OSD) manufacturing
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 Organisations is desirable, but not mandatory
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
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
Bachelor’s degree in pharmaceutical science, chemical engineering, or another relevant life-science discipline with a minimum of 8 years of industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and / or process optimization.
Alternatively a Masters’ degree with a minimum of 6 years experience or a PhD degree with minimum 4 years of industrial experience
As a leading employer in our industry, Seattle Genetics 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. .
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment.