Manufacturing Technician I, Production Support

Tanvex BioPharma Inc.; San Diego, Northern (CA, KY); On-site; USD 45,000 - 65,000; Full time

Job summary

Tanvex BioPharma Inc. is seeking a Manufacturing Technician, Production Support to perform routine GMP manufacturing activities, solution preparation, and bioprocessing support in assigned areas. Responsibilities include following SOPs/MBRs, setting up and maintaining bioprocessing equipment, and drafting/revising SOPs and batch records.

Overtime and flexible shifts may be required. Qualifications include a high school diploma or higher in life sciences with 0–3 years (or 3+ years) in

Qualifications

• High School Diploma, Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience.
• 3+ years of experience in the pharmaceutical or biotech industry.
• Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.

Responsibilities

• Perform GMP manufacturing activities in assigned areas.
• Set up, operate, maintain and clean bioprocessing equipment.
• Draft and revise SOPs and batch records.
• Address production issues and report concerns to the supervisor.
• Accurately complete and maintain equipment logs and batch records.

Skills

cGMP knowledge

Microsoft Word

Excel

Detail oriented

Team player

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree in life sciences

Job description

Description

Under supervision, the Manufacturing Technician, Production Support, will perform routine manufacturing activities in GMP manufacturing areas, solution preparation, dispensing raw material, bioprocessing support and autoclave operation. Operations will be performed according to Standard Operating Procedures (SOP), Work Instructions (WI) and Master Batch Records (MBR). Perform manufacturing steps, execute routine MBRs, and revise documents such as MBRs and SOPs as needed. Flexible shift schedules and overtime may be required.

Job Responsibilities:

• Perform GMP manufacturing activities in assigned areas.
• Perform routine cleaning activities in GMP manufacturing areas
• Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products.
• Set-up, operate, maintain and clean bioprocessing equipment.
• Demonstrate good aseptic technique.
• Perform dispensing raw material.
• Basic troubleshooting of bioprocess equipment.
• Perform manual cleaning and sterilization of parts and components.
• Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices.
• Draft and revise SOPs and batch records.
• Address production issues and report any compliance related concerns to the supervisor.

Requirements

Education and Experience:

• High School Diploma, Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience.
• High school diploma with 3 or more years of experience in the pharmaceutical or biotech industry
• Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.

Knowledge, Skills and Abilities:

• cGMP manufacturing for biological products 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.
• Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.