Job Detail

Description

Summary: 

The MSAT Principal Scientist/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 co-ordinates and 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 Principal Scientist/Engineer will play a leadership role in 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 leads Tech. Transfer and CMC projects.  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 shares his knowledge and supports and mentors Scientists, Engineers and Research associates.

Principal Responsibilities

• The technical lead and support for small molecule (drug product) manufacturing activities for clinical and commercial manufacturing internally or at CMO’s. Acts as the primary technical contact for multiple CMO’s.


• Leads strategic, technically complex and challenging Technology Transfers to CMO’s and internal manufacturing facilities.


• Provides Product Supply’s CMC leadership for new products as a member of the Global cross functional CMC team (including products outside of area of expertise).


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


• Advises and participates in the assessment and selection of CMOs considering both technical and business elements.


• 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


• Provides leadership and guidance for complex root cause investigations which may impact multiple sites/CMO’s. Root cause analysis carried out in structured manner with appropriate speed. Proposed remedial actions/plans consider both technical and business impacts. Presents proposed solutions and technical reports to internal and external stakeholders (including regulatory agencies if required).


• Acting as person-in-plant and technical advisor during tech transfer, validation studies and commercial manufacturing


• Develop, optimise 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


• Supports and mentors Scientists, Engineers and Research Associates.

Qualifications

• Demonstrated expert knowledge in DP (OSD) manufacturing and scale-up of small molecule compounds (Spray drying, milling & micronisation, API physical characterisation, blending, compaction, film-coating, encapsulation, tabletting and typical analytical tests for OSD producrs).


• Experience in DP formulation


• Experience with drafting and review regulatory submissions, responding to agency information requests and fronting agency audits.


• Experience with SM API manufacturing for oral dosage forms 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


• Experience with cross-functional/matrix project or team leadership.


• The ability to work effectively and lead small matrix and cross-functional teams 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

• Master’s degree in Chemistry/Chemical Engineering or related discipline with a minimum of 14 years relevant industrial experience


• Alternatively, Ph.D. in Organic Chemistry, Analytical Chemistry, Chemical Engineering or related discipline with 10 years of industrial experience.

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