Scientist I, Analytical Development - Process Sciences (Biologics)

Location: On-site in Louisville, Colorado, United States; Monday–Friday during standard business hours, with manager-approved flexibility. Travel up to 10%.

Annual base pay: $107,500–$118,000, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a commercial-stage biotechnology company developing immunotherapies, cell therapies, vaccines, and other biologics for cancer and infectious diseases.

What you will do

• Perform analytical testing, product characterization, and method development for biologics products, particularly proteins.
• Support internal and external method transfers, method qualification, and method validation.
• Author and review analytical methods, SOPs, protocols, reports, and technical data.
• Support process development by characterizing process improvements and developing new products.
• Maintain, calibrate, operate, and troubleshoot analytical instruments in a GMP BSL-2 laboratory.
• Collaborate with Process Sciences, Analytical Development, Manufacturing, Quality Control, Quality Assurance, Engineering, Regulatory Affairs, and Process/Product Development; train junior associates and specialists.

Requirements

• Bachelor’s degree in a scientific discipline with 8+ years of relevant experience, or a master’s degree with 6+ years of relevant experience, in a GMP or GLP-regulated biologics or biopharmaceutical environment; alternatively, a PhD with relevant industry or post-doctoral academic experience.
• Hands-on experience with HPLC or capillary electrophoresis, including CE-SDS or ic-IEF.
• Working knowledge of cGMP and pharmaceutical regulations, including 21 CFR 210/211, USP, EP, and ICH guidelines.
• Knowledge of formulation development, statistical analysis, mass spectrometry, biophysics, analytical chemistry, chromatography, cell and molecular biology, immunology, and/or virology.
• Technical writing experience preparing SOPs, analytical test reports, work instructions, qualification/validation protocols and reports, and summary reports for FDA and EMA regulatory filings.
• Ability to collaborate with contract testing laboratories and consultants while following company procedures.
• Strong communication, problem-solving, attention-to-detail, and time-management skills; ability to work effectively in a fast-moving environment.
• Ability to work on site in a GMP BSL-2 laboratory and occasionally transport small equipment, bend, squat, sit, and lift up to 40 pounds.

Nice to have

• Experience with osmolality, pH, conductivity, UV-Vis, Karl Fischer, and other analytical techniques.
• Experience with protein characterization and analytical method development.
• Experience with method qualification, method validation, or method transfer.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities within a growing, publicly traded biopharmaceutical company.
• Medical, dental, and vision plans; health and financial wellness programs; EAP; life, disability, and flexible spending benefits.
• 401(k) with company match, 529 education savings program, legal services, identity theft protection, pet insurance, and employee discounts.
• Paid time off including 11 holidays; exempt employees are eligible for unlimited PTO, while non-exempt employees receive vacation, health pay, personal days, and a cultural day.