Scientist/Principal Scientist, Clinical Manufacturing - Bothell, WA | Biospace
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Scientist/Principal Scientist, Clinical Manufacturing

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
6/21/2017
Position Type:
Full time
Job Code:
2016
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary:

Responsible for providing management and technical support of clinical stage manufacturing projects at Seattle Genetics.  The candidate will primarily support biologics manufacturing projects (antibody, ADC bulk drug substance, and drug product), but can also support small molecule chemical manufacturing projects (e.g., drug-linker).

The candidate will lead or 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.

Responsibilities:

  • Serve as CMO project manager and primary point of contact between Seattle Genetics and CMOs. Develop and maintain strong technical and business relationships with CMOs
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  • Resolve issues between Seattle Genetics and CMOs
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  • Be an active participant on internal project teams, representing the viewpoint of manufacturing
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  • Manage manufacturing schedules at CMOs to support project timelines
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  • Selection and contracting of CMOs, including drafting of RFPs and review of contracts
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  • Managing CMO budgets and tracking invoicing
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  • Support technology transfer, review master batch records, support change control process, support technical manufacturing deviation investigations, and review of executed batch records
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  • Serve as Person-in-Plant during manufacturing
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  • Work with supply chain operations to update and maintain inventory information to ensure adequate clinical supply
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  • 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
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Qualifications:

  • BS/MS/PhD 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
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  • Industry experience working with CMOs or in a manufacturing setting is preferred
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  • Excellent verbal and technical written communication skills and interpersonal skills are essential
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  • Knowledge of cGMP/ICH/FDA guidance and regulations
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Requirements

Other Requirements:

Travel required (a few times per year), depending on project