Upstream Manufacturing Associate III
Confirmed on the employer's own hiring board on Nov 9, 2026. First seen by Alion on Nov 3, 2026. Planet Pharma scores B on the Alion truth index.
Pay range: 30-40/hr
*depending on experience
Position Overview
The Upstream Manufacturing Associate III (Lead) provides technical leadership and operational coordination for upstream manufacturing activities within a cGMP environment. This role is responsible for leading batch execution, troubleshooting complex process issues, coordinating cross-functional teams, supporting manufacturing readiness, and driving operational excellence initiatives.
Key Responsibilities
Manufacturing Leadership
* Lead daily upstream manufacturing operations and provide shop-floor technical support.
* Coordinate execution of production campaigns and manufacturing schedules.
* Ensure manufacturing readiness for batch execution.
* Serve as the primary technical resource during manufacturing operations.
Upstream Processing
* Lead cell culture activities including vial thaw, seed train expansion, fed-batch and perfusion bioreactor operations.
* Oversee harvest and filtration operations.
* Monitor critical process parameters and implement corrective actions when required.
* Troubleshoot process and equipment issues to ensure uninterrupted operations.
In-Process Testing
* Perform and review manufacturing support testing utilizing:
o Cedex Cell Analyzer
o Blood Gas Analyzer (BGA)
o Osmometer
o Other process monitoring equipment
Documentation & Compliance
* Lead preparation and revision of:
o Standard Operating Procedures (SOPs)
o Master Batch Records (MBRs)
o Manufacturing forms and templates
* Support deviation investigations, CAPAs, and change controls.
* Ensure ongoing inspection readiness and GMP compliance.
* Participate directly in regulatory and client audits.
Cross-Functional Coordination
* Coordinate activities between Manufacturing, QA, QC, MSAT, Warehouse, Facilities, and Supply Chain teams.
* Support process validation, technology transfer, and commercial manufacturing initiatives.
* Drive continuous improvement and operational excellence projects.
Coaching & Development
* Train, mentor, and develop Associate I and Associate II personnel.
* Provide technical coaching and floor-based leadership.
* Support qualification and onboarding programs.
Qualifications
Education & Experience
* Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience.
* Previous leadership, lead operator, or project coordination experience preferred.
Required Skills
* Advanced expertise in mammalian cell culture and upstream operations.
* Extensive experience with fed-batch and perfusion bioreactor systems.
* Hands-on experience with Cedex, BGA, Osmometers, and related analytical equipment.
* Strong understanding of GMP regulations and manufacturing documentation systems.
* Proven leadership and decision-making abilities.
* Excellent troubleshooting and problem-solving skills.
Preferred Skills
* Experience supporting:
o Technology transfers
o Process validation
o Commercial manufacturing
o Regulatory inspections
o Continuous improvement initiatives
Physical Requirements
* Ability to stand for extended periods.
* Ability to bend, reach, and lift up to 50 pounds.
* Ability to work in cleanroom environments while wearing required PPE.