Bioprocess Development Associate – Scale-Up & Tech Transfer

BioSpace; Cambridge (MA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Retirement plan

Medical insurance

Stock incentives

Discretionary bonus

Flexible work options

Job summary

Amgen is seeking a Process Development Associate to contribute to Drug Substance Process Development for late-stage biologics, including development, characterization, and scale-up of upstream and downstream manufacturing processes.

You will work with cell culture and purification scientists across multiple modalities, performing small-scale bioprocess experiments, maintaining cultures, and supporting purification and automation efforts. Strong collaboration and communication are essential.

Qualifications

• Hands-on experience with mammalian cell culture and/or purification operations.
• Familiarity with bioprocess development and purification principles.
• Experience with design of experiments and statistical analysis of data.

Responsibilities

• Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites
• Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
• Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
• Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations
• Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems
• Experimental design and data interpretation, leveraging in-house visualization and analytics tools
• Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
• Provide scientific technical support for technology transfer of processes to manufacturing sites

Skills

Mammalian cell culture

Protein chromatography

Filtration principles

Bioprocess development

Data interpretation

Design of experiments

Statistical analysis

Education

Bachelor's degree in Chemical/Biomedical Engineering or Life Sciences

Associates degree and 2 years of scientific experience

High school diploma/GED and 4 years of scientific experience

Tools

In-house analytics tools

Job description

Amgen is seeking a Process Development Associate to contribute to Drug Substance Process Development for late-stage biologics, including development, characterization, and scale-up of upstream and downstream manufacturing processes.

You will work with cell culture and purification scientists across multiple modalities, performing small-scale bioprocess experiments, maintaining cultures, and supporting purification and automation efforts. Strong collaboration and communication are essential.