Seattle Genetics, Inc.

Manager of Fill/Finish Operations

Seattle Genetics, Inc. is a new and growing biotechnology company based in Bothell, Washington.The Company is in clinical and preclinical development with several targeted agents for the treatment of carcinomas, melanomas, and hematologic malignancies. Seattle Genetics also has an active drug discovery effort.

This individual will be responsible for identifying third party manufacturers capable of doing fill/finish, packaging, and distribution of clinical trial supplies on a global basis. This person will also manage the contracts and oversee the third party relationships. Responsibilities also include working closely with Clinical Operations to understand the supply and demand issues for multiple global clinical programs. The job also will involve managing raw materials inventory, shipping, and storage in support of bulk and finished product manufacturing.

This individual will manage our fill/finish, packaging and distribution activities. The individual will also be responsible, in coordination with clinical operations, in tracking and maintaining clinical inventory. This person will also assist in the management of all raw materials in support of bulk and finished drug supply. The job includes oversight of all interactions with fill/finish operations including the management of vendor evaluation and selection processes, schedule management, and ensuring that the vendor meets quality and regulatory standards.

Additional duties include the following:

• Defining contract manufacturing goals specific to fill/finish, packaging and distribution and ensuring that vendors meet those goals.
• Identifying potential new vendors and establishing those relationships.
• Define shipping conditions for temperature sensitive materials and ensure appropriate process validation of shipping conditions are in place.
• Coordinating the development of documentation that will support key regulatory filings.
• Working to ensure compliance with current Good Manufacturing Practices (cGMP), applicable domestic and international regulations, Standard Operating Procedures (SOPs), Batch Records (BRs), product licenses, and corporate policies.
• Represent fill/finish and raw materials issues on project teams.

Qualifications:

The successful candidate will have excellent interpersonal skills and oral and written communication skills. Minimum qualifications include a B.S. or M.S. in biology, chemistry or related sciences and a minimum of 5 years industry experience. The individual should also have a working knowledge of drug development and clinical trial supply chain management practices. Also required is a demonstrated track record over a number of years and programs dealing with third party fill/finish operations.

When applying for this position, please refer to posting #MR04-02 and let us know how you heard about the opening.

Seattle Genetics is an equal opportunity employer. We strive to find ways to attract, develop and retain highly qualified individuals representing the diverse communities in which we live.

Seattle Genetics, Inc.
Reference Job Code: MRO4-02
Attn: Human Resources
21823 30th Dr. SE
Bothell, WA 98021
Fax: (425) 527-4109
Email: hr@seagen.com

Seattle Genetics, Inc. is an Equal Opportunity Employer

Submitted: 07/28/2004