Process Development Senior Scientist (Biotechnology)

Location: United States; Corporate Headquarters in Thousand Oaks, California, with Cambridge, Massachusetts also listed

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines 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.
• Apply platform approaches and problem-solving skills to address drug substance challenges and build robust processes through efficient experimentation.
• Develop expertise in cell culture and purification while contributing to integrated process development teams.
• Collaborate with analytical and drug product representatives to deliver phase-appropriate drug substance manufacturing processes.
• Deliver processes suitable for cGMP operation and support execution in a cGMP manufacturing environment.
• Author or direct technical reports and CMC regulatory submissions.

Requirements

• Doctorate degree, or a master’s degree plus 2 years of Life Sciences experience, or a bachelor’s degree plus 4 years of Life Sciences experience.
• Experience or relevant training in chemical engineering, biochemistry, biotechnology, bioengineering, biomedical engineering, bioprocessing, pharmaceutical science, or a related discipline.
• Experience in bioreactor process development or cell line development, with knowledge of current bioreactor technologies.
• Understanding of protein characteristics, critical attributes, and product or process control strategies.
• Ability to investigate and resolve cell culture and harvest issues and lead scientific projects.
• Knowledge of design of experiments, statistical data analysis, drug development, cGMP manufacturing, and CMC regulatory submissions.

Nice to have

• Progressively expanding leadership experience and the ability to lead scientists toward complex objectives within defined timelines.
• A sustained record of peer-reviewed publications demonstrating scientific eminence.
• Experience working with diverse team members in a dynamic, cross-functional environment.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, and disability insurance, plus flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable to the role.