Associate Director, Antisense Oligonucleotide Analytical Development (Biotechnology)

Location: Cambridge, Massachusetts, United States; on-campus work

Base salary: $159,000–$219,000 per year

Company

hirify.global is a biotechnology company developing life-changing medicines through scientific innovation and collaborative drug development.

What you will do

• Lead analytical development activities for antisense oligonucleotide drug substance and drug product programs, including GMP support.
• Develop and implement analytical methods and control strategies for release, stability, characterization, comparability, and specification setting.
• Provide technical leadership for method development, qualification, validation, transfer, and lifecycle management.
• Represent Analytical Development on cross-functional CMC and asset teams, supporting risk assessment, planning, timelines, and program decisions.
• Author, review, and approve analytical content for regulatory submissions, technical reports, briefing packages, and health authority responses.
• Oversee CRO, CDMO, and testing organization activities while building team capability, automation, hiring plans, external services, and budgets.

Requirements

• Ph.D. with 6+ years, M.S. with 8+ years, or B.S. with 10+ years of relevant analytical development experience in a relevant scientific discipline.
• Demonstrated antisense oligonucleotide analytical development experience for drug substances and/or drug products.
• Experience with analytical method development, validation, transfer, stability, characterization, comparability, and specification setting.
• Knowledge of analytical development and CMC regulatory expectations, relevant ICH guidance, and GMP principles.
• Experience leading analytical workstreams, cross-functional CMC teams, external partners, and scientific staff in a matrixed environment.
• Strong written and verbal communication skills for technical and non-technical audiences.

Nice to have

• Experience supporting ASO programs through GMP manufacturing, regulatory submission, late-stage development, or commercialization.
• Expertise in impurity and degradation characterization, advanced oligonucleotide analytical technologies, and comparability assessments.
• Experience managing CRO, CDMO, and QC laboratory relationships.
• Experience with analytical automation, digital workflows, electronic laboratory systems, data analytics, or emerging technologies.
• Scientific leadership through publications, conferences, professional societies, consortia, or technical working groups.

Culture & Benefits

• Full-time employment with medical, dental, vision, and life insurance.
• Short- and long-term disability insurance, paid vacation, holidays, sick time, and parental leave.
• 401(k) participation with company matching and an employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year, plus fitness and wellness programs.
• Inclusive environment focused on scientific rigor, collaboration, innovation, operational excellence, and talent development.