Seagen

Senior Manager Manufacturing Finished Drug Product (Packaging) - Launchpad

Technical Operations & Process Sciences - Everett, Washington

Description

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!

Position Summary:

Seagen is seeking a highly motivated Sr. Manager of Drug Product that desires an opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The initial focus of this position will be to actively participate and contribute to the design, build, and operational startup of Seagen’s new clinical and commercial biologics manufacturing facility. This position will also provide strong leadership and technical expertise in drug product engineering and process automation to manufacturing staff, as well as productively collaborate with partner organizations.

Seagen’s new cGMP manufacturing facility “project Launch Pad” is being built in Everett, Washington, just North of Seattle. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

Principal Responsibilities:

• Manage the execution of all finished drug product manufacturing operations including pre-production area checks, cleaning/sterilization of rooms or equipment, coding and tray off, manual visual inspection, vial and carton labeling, and vial packaging
• Partner with the Compliance and Quality Operations groups to ensure alignment with quality directives and internal manufacturing best practices and improvements
• Participate directly in internal, external, and global health authority audits/inspections
• Develop and maintain the operations schedule in conjunction with the area management, supervisors, and planning team
• Assist in the daily coordination of workload, working directly with other managers/supervisors
• Manage equipment/process investigations, including the evaluation of new manufacturing technologies
• Proficient in Quality Systems, including investigations, change control, and corrective/preventative actions
• Authoring/reviewing/improving manufacturing documents, technical reports, and validation documents as needed
• Developing and demonstrating proficiency in process automation and business quality systems and software
• Ensure corporate and site Quality KPI targets are achieved. Partner with Manufacturing Compliance and Quality to ensure proper adherence to Quality Systems requirements
• Maintain production area are in a state of audit-readiness and staff are quality and compliance minded
• Actively develop less experienced staff through the assignment of development opportunities, coaching, mentoring, and administration of rewards and recognition
• Hire, integrate and develop high quality talent capable of delivering against the department’s goals and objectives
• Participate and support a culture of continual improvement. Effectively collaborate with cross functional partners such as Bioprocess Development, MSAT, Quality Assurance, Quality Control, Supply Chain, and Facilities
• Ensure all staff training is up to date and compliant

Required Qualifications:

• Bachelors Degree in life sciences or engineering preferred
• 10+ years of relevant GMP biopharmaceutical industry experience, including 5+ years direct staff supervisory experience
• Must be able to don gowning required for manufacturing cleanrooms
• Demonstrated ability to lead manufacturing operations teams to achieve objectives. Previous management of direct reports required
• Strong knowledge in cGMPs for the manufacturing of biological products
• Adaptable to a fast-paced dynamic business environment
• Experienced in finished drug product manufacturing (i.e., coding, visual inspections, labeling, packaging, handling/movement of naked and packaged vials)
• Good organizational and communication skills, both written and verbal, and the ability to prioritize competing tasks
• Engages in and supports a culture of continual improvement; is attentive and approachable
• Experience in preparing technical reports and presentations
• Excellent interpersonal skills with the ability to work well with others in a dynamic and highly collaborative environment
• Proven ability to work well with cross-functional teams supporting biopharmaceutical manufacturing

Preferred Qualifications:

• Experience with finished drug product processes and high potency products
• Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company
• Working knowledge of US FDA CFRs and European EMA, including ICH guidelines Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
• Mentors and provides technical advice to individuals within team
• Applies knowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technology advancement

As the leading employer in our industry in the Pacific Northwest, 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. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

The hiring pay range for this position is $133,000 to $171,600 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/11/2023