Scientist, Downstream Process Scale-Up (AAV/Cell and Gene Therapy)

Location: Waltham, Massachusetts, United States; onsite. US and Puerto Rico residents only.

Salary: $85,500–$123,500 annually

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience, advanced cell and gene therapy, data, and digital platforms.

What you will do

• Lead downstream purification manufacturing execution and scale-up from 50-L pilot through 2000-L scale, partnering with CMC teams on pre-clinical manufacturing campaigns.
• Author, review, and revise SOPs, batch records, batch reports, technical reports, and presentations.
• Analyze pilot- and large-scale DSP manufacturing data and troubleshoot manufacturing issues with relevant working groups.
• Maintain process equipment and consumables, and evaluate technologies that improve yield, cost, and cycle time.
• Support electronic batch records, process data capture, workflow enhancements, and continuous improvement initiatives.
• Develop expertise in chromatography, filtration, and purification technologies while mentoring junior staff and supporting collaborative work.

Requirements

• Master’s degree in chemical engineering, biochemical engineering, or a related discipline with at least 2 years of relevant experience, or a bachelor’s degree with at least 4 years of relevant experience.
• Significant experience with pilot- and large-scale downstream processing manufacturing unit operations, purification technologies, and operations.
• Required: hands-on experience with chromatography and tangential flow filtration.
• Experience with process technology transfers, gap analyses, and risk assessments.
• Experience drafting batch records and SOPs is required.
• Ability to work under minimal supervision, organize work effectively, communicate clearly, and represent the group in multifunctional meetings.

Nice to have

• Experience with depth filtration and/or viral filtration or inactivation.
• Experience in AAV purification development, CMC, and drug development.
• Experience with digital manufacturing solutions such as electronic batch records and electronic notebooks.
• Knowledge of product comparability, target product profiles, quality risk assessment, UV spectrophotometry, and DLS particle sizing.
• Ability to work in Biosafety Level 2 and follow safe laboratory procedures and good laboratory practices.
• Experience authoring technical reports.

Culture & Benefits

• Supportive, future-focused environment with opportunities for promotion or lateral career development in the United States and internationally.
• Health and wellbeing benefits, including healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Employee rewards and benefit programs.
• Work at the intersection of drug discovery, AI, data, and digital platforms.
• Equal opportunity employment in a culturally inclusive workforce.