Seagen is a global multi-product biotechnology company that develops and commercializes innovative 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 four 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 Seagen can be found at www.Seagen.com
Position Summary:
This position will support the manufacturing and testing of clinical and commercial GMP materials with a focus on batch/lot review. The role reports into the Senior Manager, Technical Disposition.
The role sits within a growing Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.
Principal Responsibilities:
- Manage lot review activities for clinical, late phase and commercial GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are met
- Review and manage deviations from contractors related to manufacturing and testing
- Coordinate release activities with the other team members
- Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP expectations. Communicate and resolve discrepancies with CMO’s
- Compile and manage lot files
- Enter data in to process monitoring system draft PQR sections
- Perform activities connected with the CMO independent Batch Record Review certification program
- Participate in quality system improvements.
- Author and/or revise standard operating procedures and associated work instructions
- Interface diligently with local and global teams to ensure efficient and effective communication on project status and issues
Qualifications:
- 3+ years’ experience in the regulated pharmaceutical industry, with 1-2 years in QA or manufacturing
- Strong knowledge and experience with US/EU GMPs, ICH and other applicable international regulations
- Experience with the production and testing of pharmaceuticals (biologic or small molecules)
- Experience working with contract givers preferred
- Excellent communication skills and proven ability to work well with internal and external teams
- Experience with electronic documentation management systems preferred
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
- Fluency in English is a must
- thorough understanding of local compliance, as well as a sound ethical approach to business
Education:
- Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.)
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.
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