Senior Scientist, Engineering II (Pharmaceutical Process Engineering)

Location: North Chicago, Illinois, United States

Salary: $109,500–$208,500 per year

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead late-stage development, scale-up, validation, and commercialization of oral solid dosage products.
• Scale manufacturing processes from pilot to commercial production.
• Develop and execute technology transfer strategies for internal and external manufacturing sites.
• Apply experimental design, mechanistic understanding, and modeling to process development and scale-up.
• Establish process control strategies and critical process parameters.
• Author and review regulatory CMC documentation, including CTD Module 3.2.P.2.3 content, while collaborating with Manufacturing, Quality, Regulatory Affairs, and Technical Operations.

Requirements

• Bachelor’s degree with typically 12 years, master’s degree with typically 10 years, or PhD with typically 4 years of relevant experience.
• Strong theoretical and practical knowledge of pharmaceutical process engineering.
• Experience developing and commercializing oral solid dosage forms.
• Experience scaling processes from laboratory and pilot scale to commercial manufacturing and leading technology transfers.
• Working knowledge of process characterization, PPQ, process validation, Design of Experiments, statistical approaches, Quality by Design, risk assessment, and control strategy development.
• Strong technical and regulatory writing skills, with the ability to influence cross-functional teams and drive project execution.

Culture & Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for long-term incentive programs.
• Work is performed in a regulated environment with corporate safety, conduct, material-handling, and GxP requirements.