Director, Quality Control (Biologics)

Location: Onsite in Waltham, Massachusetts, United States

Salary: $190,000–$230,000 USD base pay per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to improve outcomes for people living with genetically driven neuromuscular diseases.

What you will do

• Define and execute the strategic vision, organizational structure, capabilities, and processes for the Quality Control function.
• Lead and develop QC personnel, including training, performance management, and team development.
• Oversee external QC laboratories, analytical testing, data analysis, Certificates of Analysis, performance metrics, troubleshooting, and partner accountability.
• Review and approve analytical method qualification and validation protocols, stability protocols and reports, QC procedures, and product expiry assignments.
• Lead OOS and OOT investigations and partner with QA on change controls, deviations, CAPAs, and batch disposition support.
• Prepare analytical CMC content for IND and BLA submissions, support health-authority interactions and inspections, and coordinate with QA, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management.

Requirements

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or a related discipline; a PhD in Chemistry or Analytical Chemistry is strongly preferred.
• 12+ years of experience in Analytical Development and/or Quality Control within a GMP-regulated environment.
• Strong expertise in analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, and ELISA.
• Deep knowledge of cGMP regulations and FDA, ICH, and EU guidance, with experience supporting CMC submissions from IND through BLA and commercialization.
• Experience with compendial and product-specific analytical methods for biologics and/or small molecules, as well as external QC laboratory and vendor performance management.
• Proven leadership, strategic thinking, problem-solving, communication, negotiation, and cross-functional collaboration skills.

Nice to have

• Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays.
• Advanced degree in Chemistry or Analytical Chemistry.

Culture & Benefits

• Work in a fast-paced, highly collaborative environment focused on clinical and commercial therapeutics development.
• Contribute to programs addressing Duchenne muscular dystrophy, myotonic dystrophy type 1, facioscapulohumeral muscular dystrophy, Pompe disease, and DMD mutations.
• Collaborate across Quality Assurance, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management.