ICOS Corporation

Associate Director, Quality Control

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 role is responsible for directing all activities within the scope of the Quality Control department and includes:

• Providing direct management over a department of 25.
• Operational management of the multiple functions within the department including QC product testing (chemistry and protein chemistry), and QC microbiology.
• Strategic leadership and oversight on the development and implementation of standards and procedures for inspecting, testing and evaluating the quality, safety, purity and potency of company and client products.
• Project planning, budget development and management, headcount management, and staff development activities.
• Collaboration with operational management from other departments to resolve issues and interact with internal and external senior management.
• Establishing departmental goals and objectives, ensuring that they comply with company goals and objectives.
• Managing activities to ensure compliance with applicable GMP and GLP regulations, quality standards, and best practices by establishing/maintaining quality systems and quality oversight, both internally as well as externally with respect to QC laboratory testing.
• Training QC staff including GMP training, technical training, and career development.
• Defining, writing, and implementing ICOS QC policies and program level SOPs.
• Providing QC review and approval of GMP/GLP SOPs as necessary.
• Preparation of QC for FDA/European Agency regulatory inspections.

Requirements:

Compliance

• Working knowledge of FDA regulations (21CFR 11, 210, 211, 600 and 58) and FDA Guidelines, ICH Guidelines, and European Directives as they pertain to clinical development through commercialization.
• In-depth knowledge of quality control laboratory quality systems, lab functions and responsibilities.
• Proven ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
• Experience in establishing automated systems in a laboratory environment.

Technical

• In-depth technical knowledge of analytical methods for testing NCE’s including chemical API’s and oral solid dosage forms.
• In-depth technical knowledge of analytical methods for testing recombinant proteins/antibodies. Working knowledge of cell bank safety testing.
• Working knowledge of microbiological methods for testing product, environmental monitoring, and product contact utilities (water system, steam, air).
• Strong technical knowledge of analytical method development, optimization, transfer and validation.
• Knowledge of the drug development process, pre-IND, through NDA.

Managerial

• Excellent verbal, written and interpersonal communication skills.
• Organized and energetic self-starter willing to take advantage of an opportunity to join a high quality organization in a fast-paced environment.
• Able to prioritize work, and manage multiple projects while maintaining quality.
• Able to work well both in groups as well as independently.
• 10 to 15 years of management experience in either pharmaceutical or biotech companies or both.

Education/Experience

• Minimum of a Bachelor’s degree in Biochemistry, Chemistry, Biology or equivalent scientific experience. An advanced degree is strongly preferred.
• Minimum of 7 years in a Quality function, with significant experience managing a laboratory unit.

Other

• Must be able to travel internationally and to expect 10% of time to be devoted to business travel.
• Must be able to work in multinational and multicultural environments.

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: 2299
Karen Fenstermacher

Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer

Submitted: 11/22/2005