What are the responsibilities and job description for the Senior Manufacturing Associate I, Upstream position at TANVEX BIOPHARMA USA INC?
Job Description
Job Description
Description : SUMMARY
Under general supervision, the Senior Manufacturing Associate, Upstream, will perform routine manufacturing activities in GMP manufacturing areas including cell culture / fermentation 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. Drives projects and assignments and provides mentorship to associates. Flexible shift schedule and overtime may be required.
JOB RESPONSIBILITIES
Technical :
Perform moderately complex 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 upstream bioprocessing equipment, which includes but is not limited to fermentation skid, centrifuges, homogenizers, inline mixers, filtration skids and associated small parts.
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.
Initiates and collaborates on manufacturing related deviations, incident reports, investigation reports, CAPAs, change controls, technical reports, and validation protocols
Teamwork and Communication :
Participate in regularly scheduled team meetings to discuss ideas, troubleshoot issues, go over lessons learned and identify future projects or tasks.
May provide mentoring and coaching to colleagues, team members, or those with similar or less experience
Act as Lead when Specialist / Supervisor is unavailable.
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 3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
Bachelor's degree with 6 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
High School Diploma / GED with 8 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
Knowledge, Skills and Abilities :
Upstream experience and skills in Cell Banking, Vial Thaw and Seed Expansion, Fermentation / Cell Culture Operations, Depth Filtration, Cell Lysis, Inclusion Body Wash and Final Filtration. Aseptic Sampling of process pools and solutions. Solution Preparation, Tubing assemblies and Autoclaving Operations.
Knowledge of DeltaV automation 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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