Description

Under general supervision, the Manufacturing Associate II, Downstream, will perform routine manufacturing activities in GMP manufacturing areas including purification and the associated sub-processes/ preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Flexible shift schedule and overtime may be required.

Technical:

Perform tasks using defined protocols or procedures which contribute to the achievement of project milestones.
Perform GMP manufacturing activities in assigned areas.
Set-up, operate, maintain and clean downstream bioprocessing equipment, which includes but is not limited to chromatography systems, UF/DF and Viral filtration skids and mixers.
Perform basic troubleshooting of bioprocess equipment.
Perform manual cleaning and sterilization of manufacturing areas, parts and components.

Compliance:

Follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), plant safety guidelines and other established procedures during the manufacturing process to produce quality products.
Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the manufacturing Good Documentation Practices (GDP).
Draft and revise SOPs and batch records.

Teamwork and Communication:

Participate in regularly scheduled team meetings to discuss ideas, troubleshoot issues, go over lessons learned and identify future projects or tasks.
Address production issues and report any compliance related concerns to supervisor and/or management as soon as possible.
Fosters teamwork and is expected to suggest project improvements

Requirements

Education and Experience

Advanced degree in life sciences or related discipline with 0 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
Bachelor's degree with 3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
High School Diploma/GED with 6 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.

Knowledge, Skills and Abilities:

Downstream/Purification experience and skills in Protein Chromatography, TFF, Depth Filtration, Viral Filtration, Bulk Drug Substance Formulation, and Final Filtration. Aseptic Sampling of process pools and buffers. Buffer Preparation, Tubing assemblies and Autoclaving Operations.
Knowledge of UNICORN and Common Control Platform (CCP) Software is preferred.
Fundamental knowledge of current biologics regulations and cGMP for drug substance operation.
Proficient with Microsoft Word and Excel.
Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
Demonstrated ability to follow and document activities in written procedures and/or logbooks.
Detail-oriented, strong team player.
Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.

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