Process Development Principal Scientist (Biotech)

Location: Cambridge, Massachusetts, United States

Salary: USD 141,836.95–191,897.05 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead attribute and analytical activities for pivotal clinical process development programs involving synthetic and hybrid molecules.
• Define analytical control strategies and develop and optimize methods for late-phase clinical programs.
• Lead method transfer and support cGMP manufacturing at internal and contract manufacturing and testing sites.
• Drive product characterization for process comparability studies, regulatory filings, regulatory questions, and reference standard qualification.
• Author technical reports and analytical CMC sections and respond to analytical and product quality questions from health authorities.
• Provide scientific leadership, evaluate analytical technologies, improve department strategies, and mentor junior staff.

Requirements

• PhD, PharmD, or MD with 3 years of relevant scientific experience; or a master’s degree with 6 years of scientific experience; or a bachelor’s degree with 8 years of scientific experience.
• Experience with small-molecule analysis, including chromatographic and spectroscopic techniques, separation science, process analytical technologies, structure elucidation, and solid-state characterization.
• Experience developing, validating, transferring, and remediating methods for in-process, release, and stability testing.
• Knowledge of GLP, GMP, pharmacopeial requirements, ICH guidance, FDA guidance, analytical method validation and transfer, impurities, and genotoxic impurities.
• Strong leadership, problem-solving, decision-making, communication, technical writing, and cross-functional collaboration skills.
• Work location: Cambridge, Massachusetts, United States.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.
• Visa sponsorship is not guaranteed.