Senior Scientist (Large Molecule Analytical Development)

Location: Bridgewater, New Jersey, United States; full-time, in-person presence required. Occasional domestic and international travel of approximately 5%–15%.

Salary: $127,000–$165,500 annual

Company

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

What you will do

• Manage the internal analytical laboratory and oversee analytical activities at CROs and CDMOs.
• Lead development, optimization, qualification, validation, and transfer of analytical methods for drug substances and drug products.
• Develop strategies for quantitation, characterization, release, stability, and in-process testing of protein therapeutics.
• Design and execute experiments to evaluate the biochemical and biophysical properties of biologics.
• Prepare protocols, SOP reviews, technical reports, analytical transfer documents, and regulatory sections for INDs, CTAs, and BLAs.
• Collaborate with multidisciplinary R&D teams, internal stakeholders, contract laboratories, and external technology vendors.

Requirements

• PhD with 2 years of biopharmaceutical industry experience, Master’s with 4 years, or Bachelor’s with 6 years.
• Advanced expertise in bioanalytical chemistry and analytical method development.
• Hands-on experience with chromatography, HPLC, UPLC, GC, mass spectrometry, LC-MS, and MS/MS.
• Understanding of pharmaceutical development from preclinical research through lifecycle management.
• Strong statistical skills and ability to define problems, analyze data, and draw valid conclusions.
• Understanding of GxP, ICH, and USP/EP/JP regulatory requirements.

Nice to have

• Experience with bioinformatics, computational biology, genomics, molecular biology, structured data, or SQL databases.
• Familiarity with machine learning algorithms, single-cell or spatial sequencing analysis, Seurat, or Scanpy.
• Knowledge of FDA and EMA bioinformatics regulatory requirements, FAIR data principles, or GAMP5.
• Experience with Waters/Empower, SEC-MALS, and mass spectrometry.

Culture & Benefits

• Medical, dental, vision, and mental health coverage with annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules alongside purposeful in-person collaboration.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning, workshops, mentorship, networking, employee resource groups, and service opportunities.