Job Detail

Description

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to two marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seattle Genetics can be found at www.seattlegentics.com.

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 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.

The primary location for this role is Zug, Switzerland. Partial remote work is available. 

Responsibilities

• 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

 Qualifications:

• 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

Education:

• 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