Associate Director, Translational Bioanalytical Sciences (TBAS)

Location: Hybrid role based out of the [City, Country] office, with remote work most of the time and in-person collaboration as needed. Occasional domestic and international travel of approximately 5%–15% is required.

Salary: $164,000–$213,000 annual

Company

hirify.global is a global biopharmaceutical company developing therapies for patients with serious and rare diseases.

What you will do

• Lead regulated LC-MS/MS bioanalytical activities for small molecules, oligonucleotides, and biologic therapeutics across clinical and nonclinical programs.
• Oversee outsourced GxP method development, qualification, validation, and sample analysis for PK, PD, and biomarker endpoints.
• Set bioanalytical and biomarker strategies in collaboration with Clinical Development, Research, clinical pharmacology, clinical operations, nonclinical safety, and CRO partners.
• Provide technical expertise in sample preparation, chromatography, mass spectrometry, stability, and assay-related issues.
• Contribute to clinical and preclinical study design, laboratory manuals, protocols, reports, statistical analysis plans, and regulatory documents.
• Manage vendor governance and participate in scientific advice meetings with FDA, EMA, and PMDA.

Requirements

• PhD or MS in Analytical Chemistry, Chemistry, Biochemistry, or a related field, with at least 10 years of postdoctoral or equivalent pharmaceutical industry experience.
• Strong experience in bioanalytical method development and validation, particularly regulated LC/MS quantification for small molecules and oligonucleotides.
• Experience managing regulated low-molecular-weight LC/MS analysis through external service providers.
• Knowledge of FDA, EMA, CLSI, M10 Bioanalytical Method Validation, GxP, ICH M10, CAP/CLIA, and ISO standards.
• Advanced knowledge of mass spectrometry platforms, ionization methods, and quantitative analysis for small molecules, proteins, peptides, and oligonucleotides.
• Strong communication, presentation, collaboration, and people-management skills in a matrixed environment.

Nice to have

• Knowledge of ligand binding assays, flow cytometry, qPCR, cell-based assays, and biological sample preparation.
• Experience with LIMS systems such as Watson or similar data systems.

Culture & Benefits

• Medical, dental, vision, and mental health support, along with annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning resources, leadership programs, mentorship, employee resource groups, and service and recognition programs.