Manager, Quality Control – Stability and Sample Management at 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, 2022, and 2023

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 three years in a row.

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

Overview

Insmed is seeking a highly motivated individual who desires a significant opportunity to improve the lives of patients with rare diseases. We are looking for someone to join a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management Manager, you will be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will have commercial GMP experience in supporting stability and sample management programs.

Responsibilities

Representative responsibilities will include, but not necessarily be limited to, the followings:

• Provide hands-on leadership for the QC Stability and Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
• Potentially oversee QC technicians and directly manage individuals (includes goal setting, performance feedback, skills development, and mentoring.)
• Manage stability programs, including study initiation and sample pulls for cell banks, starting materials, intermediates, drug substances, and drug products.
• Manage reference standard and critical reagent programs, including creation, qualification, and inventory.
• Author GxP stability protocols, interim reports, and reports for stability studies.
• Manage, report, and trend stability data in JMP software and/or Labware LIMS. Escalate out of trend observations and support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a stability budget for drug product shipments.
• Own and support stability and sample management-related Deviations, CAPAs, and Change Controls. Drive related improvements.
• Participate in the deployment and configuration of software systems for stability and sample management (e.g., JMP, Labware LIMS)
• Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
• Create, maintain, and revise QC SOPs, , and associated documents.
• Manage all aspects of the stability and sample management labs including ordering supplies and maintaining laboratory equipment, stability chambers, and lab spaces and create and maintain all processes around sample chain of custody and locations. Act as the single point of contact to control distribution of all samples for release and stability testing to QC personnel.  Ensure access to GxP sample storage devices (release and stability samples) is limited to self and designated back up.
• Support inspection and client audit readiness plans. Serve as subject matter expert for stability and sample management related topics.
• Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management. Capture metric information for use in continuous improvement of areas of responsibility.
• Participate in daily and weekly operation meetings and Quality Management Reviews.Own and support stability and sample management-related Deviations, CAPAs, and Change Controls. Drive related improvements.

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Bachelor's Degree with minimum 8 years of relevant experience within the pharmaceutical industry OR MS with minimum 5 years of relevant experience within the pharmaceutical industry.
• Experience in managing GMP stability studies across all phases of drug development.
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product stability testing.
• Strong technical writing, attention to detail, organizational, and excellent analytical skills.
• Excellent presentation skills, both verbal and written.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Ability to establish and maintain cooperative working relationships with internal and external partners required.
• Ability to take initiative and work independently while effectively managing timelines required.
• Experience with JMP statistical software, Labware LIMS, and Smartsheet a plus.
• Proficiency in Microsoft Office applications and other relevant software tools (i.e., Oracle, Veeva, JMP, BMRAM, and LIMS).

Travel Requirements

up to 15%

Salary Range

$104,000 - $137,800 a year

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, regionally based
• Competitive compensation package including bonus 
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.

 

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview 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.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.