Associate Director, MSAT - Analytical Sciences (Biologics)

Location: Remote in the United States

Salary: $169,222–$253,000 per year, plus incentive opportunity

Company

hirify.global is a pharmaceutical company developing and manufacturing medicines, including biologic drug substances and drug products.

What you will do

• Lead the analytical sciences function within MSAT to support commercial manufacturing of biologics such as monoclonal antibodies and fusion proteins.
• Develop analytical control strategies, specifications, lifecycle management plans, and continuous improvement initiatives in alignment with QbD principles.
• Provide analytical subject matter expertise for technology transfers, PPQ readiness, comparability assessments, and lifecycle changes.
• Lead investigations, root-cause analyses, OOS/OOT resolution, method troubleshooting, and corrective and preventive actions.
• Oversee analytical method qualification and validation strategies for phase-appropriate and commercial requirements.
• Manage external CDMO and CRO partnerships, ensuring delivery quality, timelines, and analytical readiness.

Requirements

• PhD or MS in Analytical Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related field.
• 8+ years of relevant experience with a PhD or 12+ years with an MS in analytical development, QC, or MSAT for biologics.
• Expertise in biologics analytical methods, including HPLC/UPLC, CE, LC-MS, bioassays, ELISA, and spectroscopy.
• Experience supporting commercial biologics manufacturing, technology transfer, analytical lifecycle management, PPQ, and BLA/MAA submissions.
• Knowledge of biologics regulatory expectations, including ICH Q5, Q6B, Q8, Q14, and FDA and EMA guidance.
• Leadership experience with teams or cross-functional technical groups, plus experience with CDMOs/CROs, statistical tools, and LIMS.

Culture & Benefits

• Remote work arrangement for the United States.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
• Tuition reimbursement, student loan assistance, and a generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.