Job Title: Manufacturing Technician – Downstream

Work Location: Alameda County, California

Summary:

The Manufacturing Technician – Downstream supports day-to-day GMP manufacturing operations within downstream processing suites. This role is responsible for the execution of purification processes under approved batch records and SOPs, supporting chromatography, tangential flow filtration (TFF), buffer preparation, and filtration operations. The technician works closely with supervisors and cross-functional partners to ensure manufacturing activities are completed safely, efficiently, and in compliance with cGMP requirements.
This position is well-suited for an early-career professional with 1–2 years of downstream or GMP manufacturing experience looking to grow technical expertise in a regulated biopharmaceutical environment.

Responsibilities:

• Execute downstream unit operations including buffer preparation, chromatography (ÄKTA systems), TFF/UFDF, depth filtration, viral inactivation, and virus filtration under GMP conditions.
• Set up, operate, monitor, and break down downstream processing equipment and single-use systems per approved procedures.
• Perform solution preparation activities including weighing, mixing, pH adjustment, filtration, labeling, and staging of buffers and process solutions.
• Conduct in-process sampling and support process monitoring activities during purification runs.
• Assist with equipment setup, cleaning, and changeover for downstream manufacturing suites.
• Perform basic equipment troubleshooting and escalate issues to supervisors or engineering as appropriate.
• Support equipment qualification, calibration, and validation activities through protocol execution and documentation.
• Maintain readiness of downstream suites through routine checks and material staging.
• Accurately execute and document manufacturing activities using approved batch records, SOPs, and logbooks.
• Complete documentation in compliance with cGMP and cGDP requirements.
• Support review of batch documentation for completeness and accuracy.
• Adhere to site procedures, safety standards, and cleanroom practices at all times.
• Maintain required GMP training and qualification status.
• Support training of peers once qualified and under guidance of leadership.
• Work collaboratively with Manufacturing Supervisors, MSAT, Quality, and Supply Chain to support manufacturing timelines.
• Participate in shift handovers to ensure clear communication of process status and issues.
• Identify and promptly report deviations, non-conformances, or equipment issues.
• Support investigations, deviations, CAPAs, change controls, and area walkthroughs as assigned.
• Contribute to continuous improvement initiatives by identifying opportunities to improve efficiency, safety, or compliance.
• Maintain cleanroom housekeeping and gowning standards per SOPs.
• Perform additional duties as assigned to support downstream manufacturing operations.

Working Conditions:

• Work performed in GMP cleanroom and laboratory environments, with some office-based documentation work.
• Requires standing, walking, bending, kneeling, and working in cleanroom attire for extended periods.
• Must be able to lift and move up to 20 pounds independently.
• Flexibility to support shift work, weekends, or holidays as needed.

Qualifications:

• BS in Life Sciences, Engineering, or a related discipline with 1–2 years of relevant GMP or biopharmaceutical manufacturing experience.
• Prior experience in downstream processing, purification, or related GMP operations is strongly preferred.
• Hands-on experience or exposure to downstream purification processes, including chromatography and/or TFF.
• Familiarity with ÄKTA chromatography systems and buffer preparation techniques.
• Basic understanding of cGMP regulations and controlled documentation practices.
• Experience following batch records and SOPs in a regulated environment.
• Exposure to single-use technologies and GMP cleanroom operations.
• Familiarity with process control or data systems such as UNICORN or similar.
• Experience supporting investigations or deviation documentation.
• Strong attention to detail and commitment to data integrity.
• Ability to follow procedures and execute tasks accurately.
• Effective communication skills and ability to work in a team environment.
• Willingness to learn, adapt, and grow in a fast-paced manufacturing setting.
• Strong organizational skills with the ability to manage multiple tasks.

Published Category: Manufacturing & Technical Operations