| Job Description | Job Description
Responsible for providing management and technical support of manufacturing projects of Seattle Genetics’ clinical programs. The candidate will primarily support biologics manufacturing projects (antibody, ADC bulk drug substance, and drug product), but is open to supporting chemical manufacturing projects (drug-linker).
The candidate will be part of internal project teams and work with colleagues in process and analytical development, quality assurance, quality control, supply chain operations, and other functional areas. The candidate will manage and provide oversight of various contract manufacturing organizations (CMOs) that perform manufacturing for Seattle Genetics. The candidate is expected to establish and maintain open and collaborative relationships with both internal and external (CMO) partners.
The candidate is expected to monitor and improve the performance of CMOs and manufacturing processes. Through the use of best practices and application of new manufacturing technologies, the successful candidate will streamline manufacturing activities and help gain efficiencies in resources and timelines.
Duties
• Serve as CMO project lead and primary point of contact between Seattle Genetics and CMOs. Develop and maintain strong technical and business relationships with CMOs. Resolve issues between Seattle Genetics and CMOs.
• Be an active participant on internal project teams, representing the viewpoint of manufacturing.
• Manage manufacturing schedules at CMOs to support project timelines.
• Selection and contracting of CMOs, including drafting of RFPs and review of contracts. Managing CMO budgets and tracking invoicing.
• Support technology transfer, lead review of master batch records, lead change control process, lead technical manufacturing deviation investigations, and lead review of executed batch records.
• Serve as Person-in--Plant during manufacturing, as required.
• Work with supply chain operations to update and maintain inventory information to ensure adequate clinical supply.
• Support process changes (e.g., scale-up, site transfer) and improve manufacturing processes by application of facility fit, equipment know-how, and novel manufacturing technologies.
Requirements
QUALIFICATIONS/REQUIREMENTS:
• Bachelor’s degree in Chemical Engineering, Biochemistry, Biology, Chemistry, Microbiology or related scientific field and a minimum of 5 years of experience in the biotechnology or biopharmaceutical industry.
• Industry experience in a manufacturing setting or working with CMOs is preferred.
• Excellent verbal and technical written communication skills and interpersonal skills are essential.
• Knowledge of cGMP/ICH/FDA guidance and regulations.
OTHER REQUIREMENTS:
• Travel required (10-20%), depending on project. |
| | Company | | Seattle Genetics | Job Code | | State or Province | | Washington | | |
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