Director, Quality Control

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Job description

Company Description

About Insmed:

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Overview

About the Role:

Insmed is seeking a director of QC. This individual will be responsible for establishing a QC laboratory to support product release. This role will manage Quality Control operations at CMO and contract testing laboratories, including managing contract relationships in parallel with implementing in-house testing. Stability program, reference standard testing, in-process, and release testing will be required throughout the product lifecycle for all Insmed Programs.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

* Establish laboratory and participate in hiring QC staff
* Manage external CMO partners
* Participate in assay transfer
* Establish reference standard and stability programs

Qualifications

About You:

* PhD in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, or equivalent science program
* Minimum of 15 years of experience in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with at least 10 years in a GMP QC release testing role
* Significant experience in an FDA-regulated environment
* Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic.
* Strict adherence to environmental, health, and safety guidelines.

Travel Requirements

Up to 15% travel, both domestic and/or international.

Additional Information

This role is to be filled outside Colorado.

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.