ICOS Corporation

Regulatory Affairs, CMC, Principal

ICOS Corporation, based in the Seattle, Washington area, has spent more than a decade building a world-class research and development organization. Cialis is currently available in approximately 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. ICOS is committed to advancing science in the areas of protein based and small molecule therapeutics.

Working at ICOS gives you the opportunity to work with a brilliant team of scientists using sophisticated equipment and research methodologies to tackle cutting edge scientific projects.

Responsibilities:

This position focuses primarily on the CMC aspects of supporting drug and biologic products in development, the licensing of new products, and support of marketed drug products. This position is the regulatory representative for CMC initiatives including developing and directing regulatory strategies and programs for biopharmaceutical process changes designed to support product production. Responsibilities of the position also include providing functional expertise and oversight on regulatory compliance, adherence to GMPs, and department/product team leadership for the execution of CMC regulatory programs.

The position is responsible for:

• Providing guidance and support to the manufacturing development teams.
• Preparing FDA/EU filings and annual reports.
• Preparing CMC sections of INDs, CTAs, and marketing applications.

The position interacts with all levels of biopharmaceutical manufacturing, quality control, quality assurance, and regulatory affairs and is the primary internal and regulatory agency interface on CMC issues.

Requirements:

• BS/MS degree in Pharmaceutics, Chemistry, Chemical engineering, Biochemistry, Pharmaceutical Science or other life sciences discipline.
• Minimum of five to seven years of experience in biopharmaceutical sciences at a pharmaceutical and/or biotech company.
• Five years of direct experience in Regulatory Affairs managing CMC-related issues.
• Small molecule experience essential.
• Demonstrated ability to work collaboratively in a team environment.
• Demonstrated leadership on cross-functional teams in pharmaceutical industry.
• Clear written and verbal communication skills.

ICOS offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

For immediate consideration please email your CV to Karen Fenstermacher at kfenstermacher@icos.com highlighting the position in the subject line or visit www.icos.com and apply directly for this position.

Learn more about ICOS philosophies, attributes, financial information, and more by visiting our web site at: www.ICOS.com.

ICOS Corporation
Reference Job Code: 2166
Karen Fenstermacher

Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer

Submitted: 11/22/2005