Manufacturing Associate 2 (Downstream) - Day Shift (2-2-3)

About the role

We are hiring a Manufacturing Associate 2 to support both project-phase readiness and steady-state operations in a 24/7 facility. This position plays a crucial role in ensuring the safe, consistent, and efficient production of drug substance.

Responsibilities

• Contribute to project-phase operational readiness for bulk drug substance manufacturing.
• Support procedure review/creation and development or transfer of manufacturing business processes.
• Provide testing and commissioning support for equipment/systems; travel up to 0–25% (domestic or international) may be required.
• Execute and document manufacturing processing steps and support activities; perform process monitoring and control per cGMP standards.
• Perform in-process testing (e.g., pH, conductivity, visual inspection).
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs).
• Maintain required training and qualifications for all assigned activities.
• Work assigned shifts in a 24/7 operation, including weekends and potential nights.
• Perform other duties as assigned.

Requirements

• A high school diploma or GED and 2 years of related experience (or equivalent combination of education and experience).
• 2+ years of direct experience in a cGMP manufacturing environment.
• Knowledge of support process equipment and understanding of cGMPs, safety, and operational procedures.
• Ability to follow technical instructions, perform operations, and document accurately.
• Strong verbal and written communication; ability to work effectively in a team.
• Ability to adapt in a fast-paced, changing environment.
• Willingness to work shifts (including weekends/nights) and travel up to 0–25% as needed.

Preferred Qualifications

• A degree in Life Sciences or a related field.
• Qualified in a support area (e.g., Formulation Buffer Prep, Media Prep, or DSM Buffer Prep) through internal or post-hire training.
• BioWorks or BTEC Capstone cGMP coursework.

Physical Requirements

• Standing and/or sitting for prolonged periods.
• Performing repetitive motions involving wrists, hands, and fingers.
• Working in proximity to production equipment and utilities.
• Lifting or moving materials as required by task-specific SOPs and safety guidelines.

Benefits

Our company offers a dynamic work environment and cultivates a culture that fuels your purpose, energy, and drive—what we call Genki. Join us in shaping the future of medicine and transforming healthcare together!

Pay

Details on pay are not specified in the job posting.

Schedule

The position requires working assigned shifts in a 24/7 operation, including weekends and potential nights.