Process Development Scientist (Biotechnology)

Location: Cambridge, Massachusetts, United States; may telecommute.

Annual salary: $111,685–$144,605, plus stock, retirement, insurance, and potential annual bonus.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for patients worldwide.

What you will do

• Provide technical input for drug product commercialization and synthetic process development.
• Design and execute characterization studies covering manufacturing processes, production scale, equipment, and raw material changes.
• Support process scale-up, technology transfers, commercialization, and lifecycle management for pipeline and commercial products.
• Author process transfer documents, technical reports, regulatory submission sections, and Module 3 documents.
• Apply scientific, engineering, and statistical principles to nonconformance investigations and corrective/preventive actions.
• Collaborate with engineering, analytical, quality, regulatory, clinical, and commercial manufacturing teams.

Requirements

• Master’s degree or foreign equivalent in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field.
• At least 2 years of experience in the offered role or a related Scientist position.
• Experience with statistical evaluations, process capability analysis, data simulations, and statistical monitoring plans.
• Experience with process scale-up, technology transfer, gap analysis, root cause analysis, risk assessment, and process validation.
• Experience authoring and reviewing Module 3 regulatory documents and responding to health authority requests.
• Laboratory skills including chemical weighing, dispensing, pipetting, aseptic handling, and bench-scale fill-finish operations in a biosafety cabinet.

Culture & Benefits

• Work alongside scientists and professionals across research, manufacturing, and product delivery.
• Benefits include stock, retirement plans, medical, life, and disability insurance.
• Eligibility for an annual bonus.
• Remote work may be available.