Manufacturing Associate 4 (Downstream) - Day Shift (2-2-3)
On-siteHolly Springs, North Carolina, United States
Job Summary
Lead and execute manufacturing processing steps and support activities while performing process monitoring and control per cGMP standards. Contribute to operational readiness for bulk drug substance manufacturing by supporting procedure review, creation, and development of manufacturing business processes. Provide testing and commissioning support for equipment and systems, including in-process testing such as pH and conductivity checks. Assist with daily scheduling and materials oversight for the manufacturing team, managing cycle counts and assigned area materials. Execute validation protocols according to cGMP SOPs and maintain required training for all assigned activities. Work assigned shifts in a 24/7 operation, including weekends and potential nights, with up to 25% domestic or international travel during the project phase.
Required Qualifications
- High School Diploma or GED
- 6+ years of experience in life sciences manufacturing
- Associate degree
- 4+ years of experience in life sciences manufacturing
- BA/BS
- 2+ years of experience in life sciences manufacturing
- Equivalent military training/experience
- Advanced understanding of manufacturing run cadence and order of shift activities
- Knowledge of cGMPs, safety, and operational procedures
- Strong troubleshooting ability
- Demonstrated expertise with operation of specific production equipment
- Ability to follow technical instructions, execute operations, and document accurately
- Strong verbal and written communication
- Effective team collaboration skills
- Strong time management
- Ability to adapt in a fast-paced, changing environment
- Willingness to work shifts (including weekends/nights)
- Travel up to 0–25% as needed
Desired Qualifications
- BioWorks or BTEC Capstone cGMP coursework
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