Job Title: Manufacturing Specialist
Location: Philadelphia, PA 19104
Pay rate: $22.00 - $23.43/ hr
Work schedule: Full-Time | Shift Details Not Specified
The Manufacturing Specialist performs hands-on clinical and commercial vector manufacturing operations within a current Good Manufacturing Practices (cGMP) environment. This role encompasses both upstream virus production and downstream purification processes. In addition to executing technical production, the specialist is responsible for preparing critical process support materials, maintaining instrumentation records, reviewing core manufacturing documentation, and supporting investigations into process deviations.
Key Responsibilities
Hands-on Processing: Execute end-to-end cGMP manufacturing runs, actively managing both upstream virus production stages and downstream purification sequences.
Support Material Prep: Formulate and prepare required manufacturing support materials, including specialized media batches and process buffers.
Equipment Assembly: Prepare and set up core manufacturing instrumentation, including the packing of chromatography columns utilized for clinical and commercial vector production.
Deviation Investigations: Participate in formal investigations of process deviations by conducting targeted data gathering, analyzing trend profiles, and presenting findings as required.
Document Review: Review manufacturing documents, standard operating procedures (SOPs), and active batch records to ensure compliance during virus production and purification phases.
Process Calculations & Tracking: Perform routine mathematical calculations associated with production runs and meticulously maintain appropriate facility, equipment, safety, and compliance records.
Process Transfer Support: Contribute to the ongoing monitoring of manufacturing processes during product transfers from the research phase to active manufacturing, as needed.
Must Have Skills / Requirements
cGMP Expertise: Solid foundational knowledge of current Good Manufacturing Practices within a highly regulated cleanroom setting.
Bioprocess Equipment Operations: Practical experience handling chromatography columns, upstream bioreactor or flask processing, and downstream purification units.
Analytical Mindset: Competency in gathering data, identifying process trends, and performing foundational mathematical equations.
Technical Literacy: Strong eye for detail required to thoroughly audit batch records and modify technical SOPs.
Education & Experience
Experience: 2–5 years of professional working experience directly within a manufacturing environment.
Education: Minimum of a Bachelor’s Degree is required (preferably in Life Sciences, Bioengineering, or a related technical field).
Term: 12-Month Contract Assignment
Assignment Duration: 07/06/2026 to 07/02/2027