Associate Director, Analytical Development & Quality Control (Biotech)

Location: US-based remote position; preference for New England candidates able to work from the Boston office one day per week. Monthly or quarterly travel to the Boston headquarters is required.

Salary: $172,000–$202,000 per year.

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines that engage intracellular targets for neuromuscular and inherited retinal diseases.

What you will do

• Lead late-stage analytical development and quality control activities for oligonucleotide drug substances and drug products.
• Partner with internal teams and external CDMOs on process performance qualification campaigns, commercial manufacturing, and GMP readiness.
• Develop AD&QC strategies supporting regulatory submissions and commercial product readiness.
• Lead analytical method lifecycle activities, including method transfer, validation, verification, comparability assessments, and performance monitoring.
• Establish and maintain analytical specifications, sampling plans, quality risk assessments, and critical quality attribute limits.
• Represent AD&QC during health authority inspections, partner audits, quality assessments, and regulatory responses.

Requirements

• Ph.D. in Organic Chemistry, Analytical Chemistry, or a related discipline.
• At least 6 years of late-stage and commercial AD&QC experience in the biotechnology or pharmaceutical industry.
• Experience with oligonucleotide programs, especially PMO and PPMO, and with cGMP manufacturing requirements.
• Extensive experience with IND, IMPD, NDA, MAA, and post-approval regulatory filings.
• Strong knowledge of ICH, FDA, EMA, USP, and Ph. Eur. requirements for oligonucleotide drug products.
• Excellent written and verbal communication, attention to detail, and ability to manage multiple high-priority tasks.

Culture & Benefits

• Mission-driven, collaborative environment focused on developing therapies for patients with rare diseases.
• Comprehensive health, dental, and vision coverage, plus life and disability insurance.
• 401(k) matching, paid gender-inclusive parental leave, education reimbursement, and discretionary time off.
• Holistic health and well-being support and commuting benefits aligned to the working model.