Manufacturing Bioprocess Associate (Downstream)

Location: Site-based in Baltimore, Maryland, US; the schedule may include nights, weekends, holidays, and other off-shift coverage to support 24/7 manufacturing operations.

Company

hirify.global is a contract research, development, and manufacturing organization providing integrated scientific services to pharmaceutical, biotechnology, animal healthcare, consumer goods, and agrochemical companies.

What you will do

• Execute downstream biologics manufacturing operations, including chromatography, tangential flow filtration, buffer preparation, and process equipment operation.
• Set up systems, tubing configurations, and filter integrity tests; operate glass wash and autoclave systems.
• Perform cleaning, sanitization, line clearance, and cleanroom activities.
• Complete Master Batch Records, SOPs, logbooks, and other documentation under cGMP requirements.
• Support new product introductions, facility and equipment readiness, process performance qualification batches, and commercial launch preparation.
• Participate in deviation investigations, root cause analysis, CAPA development, process improvements, and 5S activities.

Requirements

• Associate or bachelor's degree in a science-related field, or equivalent relevant experience.
• 2–4 years of biologics manufacturing experience in upstream or downstream operations.
• Working knowledge of GMP documentation, cleanroom behavior, and aseptic techniques.
• Understanding of upstream cell culture or fermentation and downstream purification unit operations.
• Experience with new facility startup, equipment commissioning or qualification, and client-sponsored manufacturing or CDMO operations.
• Ability to work on a fluid schedule supporting 24/7 operations, including nights, weekends, and holidays, in a site-based manufacturing environment.

Culture & Benefits

• Safety is treated as a core responsibility alongside business performance.
• Work involves collaboration with MSAT and Process Development teams during process introduction and technology transfer.
• The position may require approximately 5–10% travel, including possible international travel, based on business needs.
• The manufacturing environment may include extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gases, fumes, steam, or chemicals.