Process Development Senior Scientist (Biotechnology)

Location: Cambridge, Massachusetts, United States

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

• Develop, characterize, scale up, and support drug substance processes for programs progressing from Phase II/III trials to marketing application.
• Apply platform approaches and efficient experimentation to solve drug substance development challenges and build robust processes.
• Develop capabilities in cell culture and purification while contributing to integrated process development activities.
• Collaborate with cell culture, purification, analytical, and drug product scientists across drug substance teams.
• Deliver processes suitable for cGMP operation and support manufacturing activities in a cGMP environment.
• Author or direct technical reports and CMC regulatory submission content.

Requirements

• Doctorate degree, or a master's degree with 2 years of life sciences experience, or a bachelor's degree with 4 years of life sciences experience.
• Advanced degree or relevant industry experience in chemical engineering, biochemistry, biotechnology, bioengineering, biomedical engineering, or bioprocessing.
• Experience with bioreactor process development or cell line development.
• Knowledge of bioreactor technologies, protein characteristics, critical attributes, and product or process control strategies.
• Experience resolving cell culture and harvest issues, leading scientific projects, and communicating technical findings.
• Knowledge of design of experiments, statistical analysis, drug development, cGMP manufacturing, and CMC regulatory submissions.

Nice to have

• Leadership experience with progressively increasing scope and the ability to lead scientists toward complex objectives.
• A sustained record of peer-reviewed publications and recognition in the scientific community.
• Experience working in diverse, dynamic, cross-functional teams.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, 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.
• Flexible work models where applicable to the role.

Hiring process

• Applications remain open until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.