Manager, Quality Control – Stability and Sample Management

Insmed Incorporated • San Diego, CA

2d • Onsite

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Manager, Quality Control – Stability and Sample Management on the Quality Control team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, QC Operations, you’ll be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. What You'll Do: In this role, you’ll have the opportunity to 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. You’ll also: 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, clientand 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.

Requirements

• You have a Bachelor’s degree along with 8 years of experience in the pharmaceutical, or a Master’s degree with minimum 5 years of relevant experience.
• 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.
• Proficiency in Microsoft Office applications and other relevant software tools (i.e. Oracle, Veeva, JMP, BMRAM, and LIMS).

Nice To Haves

• The ideal candidate will have commercial GMP experience in supporting stability and sample management programs.
• Experience with JMP statistical software, Labware LIMS, and Smartsheet a plus

Responsibilities

• 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, clientand 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.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Manager