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Technical Product Owner Small Molecule
vor 4 Monaten
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us
Summary:
Principal Responsibilities:
- Work in collaboration with the Strategic Product Supply Lead (SPSL) to develop and execute Product Supply manufacturing strategies
- Be accountable for the provision of technical oversight for manufacturing activities for clinical and commercial manufacturing of Drug Linkers/SM API’s at CMO’s. Ensuring that manufacturing process are and remain aligned across manufacturing sites/CMOs
- Partner with the Internal/External Manufacturing Manager and the Quality Steward to ensure the robustness of the manufacturing process, product quality and continuity of supply
- Provide overall technical leadership for the Drug Linker manufacturing process working in close collaboration with MSAT SMEs
- Be accountable for the Technology Transfers into manufacturing facilities (internal or external). Review and write key technical elements of regulatory submissions and respond to agency requests for information
- Support the Drug Linkers/AM APIs throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification)
- Provide guidance for root cause investigations of process related deviations in a timely, comprehensive, and conclusive manner. Lead the data analysis of process data statistics, identify process deviations, assess product impact, prepare technical reports, and propose process solutions and improvements
- Provide guidance for comprehensive facility fit assessments and gap analysis for the relevant part of GMP manufacturing
- Work cross-functionally to support 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
- Interface 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. Identify and initiate process and procedural changes to improve process performance, robustness, productivity, safety, efficiency, and compliance
- Advise on Scientific and Business developments (including Technologies, Processes, Products, Input Materials, Regulations etc.). Support Due Diligence activities, CMO selections etc.
- Coach and share knowledge across Technical Operations
Qualifications:
- Extensive scientific and technical experience within relevant development and/or manufacturing technologies and unit operations relating to SM API/Drug Linker manufacturing. Experience with small and commercial scale equipment utilized in cGMP manufacturing facilities (including clinical manufacturing)
- Experience of senior technical leadership
- 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 required
- Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seagen
- 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**:
- An educational background in Chemistry, Chemical Engineering, or another relevant life-science discipline with industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and/or process optimization:
- BS and 12+ years of experience
- MS and 10+ years of experience
- PhD and 7+ years of experience
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