Manager, Quality Control Molecular Biology
Insmed Incorporated

San Diego, California

This job has expired.


Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science's 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's 2021 Top Employers Survey.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma™ List, Small and Medium, and one of the Best Workplaces in New York™️️, which recognizes companies headquartered in NY, NJ, and CT.

Overview

Insmed is seeking a manager of QC with broad knowledge and expertise in immunoassays, cell-based assays, molecular biology assays, and chemical/biochemical assays. This individual will be responsible for establishing a QC laboratory and maintain the lab in GMP-compliant status to support product release. This role will be involved in developing, qualifying, and validating robust QC methods to support product release and characterization by collaborating with internal functions groups and external CDMO/CTLs. In addition, this individual will be responsible for management of test samples, stability program, and reference standards.

Responsibilities

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

Representative responsibilities will include, but not necessarily be limited to, the following:
• Collaborate with research, analytical and process development teams to develop, qualify/validate molecular biology assays such as ddPCR and qPCR assays, immunoassays and/or protein chemistry assays for process monitoring and drug product release
• Collaborate with research, analytical and process development teams to determine critical quality attributes (CQAs), monitor process and method performance, and troubleshoot
• Develop timelines and protocols for assay transfers, qualifications and validations
• Establish specifications for drug substance and drug products
• Author, review, and approve QC analytical SOPs, protocols, and reports
• Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
• Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results
• Establish sample plans, manage in-process and release test samples
• Establish stability plans, manage stability tests and reference standards
• Manage QC laboratory, track critical reagents and logbooks, and ensure all the equipment is calibrated
• Establish laboratory and participate in hiring QC staff

Qualifications

About You:

• PhD in relevant discipline with a minimum of 5 years of relevant industry experience or Master's degree in relevant discipline with a minimum of 8 years of relevant industry experience
• Experiences 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 experience in a GMP QC release testing role
• Experiences in developing methods with particular emphasis on immunoassay, cell-based potency assay, molecular biology assay, and protein chemistry assays
• 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
• Excellent organizational and communication skills
• Experience with direct reports or managing people

Travel Requirements

Up to 5% travel.

Additional Information

Insmed Incorporate d 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.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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.

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