Associate Scientist, Quality Control Chemistry
Insmed Incorporated

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 Top Employer in 2021 and 2022

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 Top Employers Survey for two years in a row.

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 TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.

Overview

Insmed is seeking a QC associate Scientist with prior experiences in development and qualification of HPLC methods for releasing testing. This individual will be responsible for establishing QC testing methods for detection of detergent chemicals and proteins using HPLC and CE-SDS system. Prior experience in analytical ultracentrifugation (AUC) and rare metal by ICP-MS is highly preferred. This individual shall be able to author/implement QC area procedures. Other assignments may include QC support required throughout the product lifecycle for all Insmed Programs.

Responsibilities

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

• Collaborate with research, analytical and process development teams to develop, qualify/validate and run chemistry and 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

• Bachelor's degree in relevant discipline with a minimum of 5-8 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 HPLC assays, protein chemistry assays such as CE-SDS and analytical ultracentrifugation (AUC) 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

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $84,000.00 to $118,667.00

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

Additional Information

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.

This job has expired.