Manager, Quality Control

About the role

We’re looking for a Manager, Quality Control on the Quality Control team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Quality Control, you’ll be responsible for overseeing and performing the testing of HPLC and compendial methods. Additional responsibilities include, but are not limited to, establishing/qualifying QC test methods, authoring/revising SOP’s, and managing quality events.

Responsibilities

• Ensure the timely execution of all routine QC testing, data review/trending, and preparation of summary reports.
• Perform and oversee quality events such as deviation, CAPA, change control, investigation of OOS, OOT and atypical results within the company QMS according to established procedures.
• Author, review, and approve QC analytical SOPs, protocols, and reports.
• Function as SME for HPLC, CE-SDS, pH, Osmolality, appearance, ICP-MS and DLS.
• Develop timelines and protocols for assay transfers, qualifications and validations. Support method transfer activities between lab and CDMO’s.
• Manage QC laboratory, track critical reagents and logbooks, and ensure all the equipment is calibrated.
• Utilize software to perform routine laboratory activities (Labware LIMS, JMP, Chromeleon, etc.). Participate in implementation of new software and updates as a subject matter expert.
• Establish laboratory and participate in hiring and training of QC staff.

Requirements

• You have a Bachelor’s degree along with 7+ years of experience in quality control.
• You are or you also have:
• Experiences in a gene therapy company 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, elemental analysis by ICP-MS, protein purity by CE-SDS, and compendial methods.
• Significant experience in an FDA-regulated environment
• Excellent organizational and communication skills
• Experience with direct reports or managing people

Qualifications

• You have a Bachelor’s degree along with 7+ years of experience in quality control.
• You are or you also have:
• Experiences in a gene therapy company 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, elemental analysis by ICP-MS, protein purity by CE-SDS, and compendial methods.
• Significant experience in an FDA-regulated environment
• Excellent organizational and communication skills
• Experience with direct reports or managing people

Skills

• Author, review, and approve QC analytical SOPs, protocols, and reports
• Function as SME for HPLC, CE-SDS, pH, Osmolality, appearance, ICP-MS and DLS
• Develop timelines and protocols for assay transfers, qualifications and validations
• Manage QC laboratory, track critical reagents and logbooks, and ensure all the equipment is calibrated
• Utilize software to perform routine laboratory activities (Labware LIMS, JMP, Chromeleon, etc.)
• Establish laboratory and participate in hiring and training of QC staff

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

Pay

$124,000.00-161,000.00 Annual