JT389 - ASSOCIATE PILOT PLANT

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Supports the execution of cell culture process to include, not limited to; aseptic vial thaw & cell culture flask passaging in biosafety cabinet through benchtop wave bioreactors & 200L & 500L single use bioreactors.
• May support large scale harvest operations through downstream purification to include, but not limited to; chromatography, filtration, as well as, Ultra-Filtration/Diafiltration (UF/DF) using various Pilot Scale skids & equipment
• Furthermore, may perform additional routine tasks to include, but not limited to; in-process sampling, operation of laboratory analyzers, management of samples, scientific data collection via electronic laboratory notebook(s), compounding media/buffer solutions, Clean-In-Place (CIP), Steam-In-Place (SIP), equipment assembly & disassembly, routine maintenance of benchtop analyzers, escort & provide oversight of vendors, inventory stocking as well as, general lab organization & cleaning
• Utilizes scientific principles in execution of experiments & analysis of experimental data
• Carries out laboratory tasks per plan & procedure in a team environment
• Documents data & process information in accordance with good documentation practices
• Performs laboratory safety evaluations
• Performs minor equipment maintenance
• Helps maintain laboratory standards with a focus on safety, quality, and compliance

Qualifications: 

• Bachelor’s degree in a related science or engineering field (e.g., biology, chemistry, biopharmaceutical sciences).
• Technical Skills: Experience in cell culture (mammalian or microbial) is crucial, including aseptic handling and familiarity with bioreactors
• Some exposure to chromatography, filtration (UF/DF), and data analysis
• Basic knowledge of process automation systems and scientific documentation, including notebooks and batch records
• Prior hands-on experience in pilot- or large-scale cell culture or downstream purification process development or manufacturing
• Experience with automated computer-controlled biopharmaceutical equipment
• Knowledge of process data compilation and analysis
• Demonstrated problem-solving capabilities and excellent attention to detail
• Excellent written and verbal communication skills
• Primarily Monday to Friday with flexibility between 7 AM - 5 PM, but some weekend work may be required on a volunteer or rotational basis.
• Must be able to sit on-site, shifts may be flexible