Bioprocessing Associate I

Germer International; King of Prussia (PA); On-site; USD 55,000 - 75,000; Full time

Job summary

Germer International seeks a Bioprocessing Associate I for Manufacturing in King of Prussia, PA. The role involves manufacturing Master and Working Cell Banks, and Cell & Gene Therapy products in a cGMP environment, with emphasis on teamwork and strict adherence to SOPs and batch records.

The ideal candidate will have a science background, experience with aseptic technique, BSC handling, and familiarity with SAP, Veeva, and LIMS systems.

Qualifications

• H.S./Assoc with 2+ years of experience or BS (science preferred) with 0-2 years.
• General knowledge of cGMP regulations.
• Experience using a Biological Safety Cabinet (BSC).
• Familiar with cell expansion vessels and purification equipment.

Responsibilities

• Understand concepts of aseptic technique.
• Train, maintain and operate equipment.
• Participate/perform in tech transfer activities.
• Assist with validation execution.
• Received and organizes materials.
• Identify/communicate discrepancies of material deliveries.
• Use of SAP, Veeva, LIMS, etc.
• Follow GMPs and batch records.

Skills

Aseptic technique

cGMP knowledge

Team collaboration

Problem solving

Learn production equipment

Education

High School Diploma or Associate degree

BS in Life Sciences

Tools

SAP

Veeva

LIMS

Job description

Position Summary

The Bioprocessing Associate I for Manufacturing will be responsible for the manufacture of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). The incumbent will be responsible foroperatingupstream and downstream equipmentfor adherent and suspension systemsand performing production support activities while maintaining compliance to cGMP standards. We are looking for individualsthatare willing to work withina team,arehard-working, and highly motivated.This position requires multi-tasking and excellentpeer-to-peercommunicationskills.

Primary Responsibilities

• Understand concepts of aseptic technique.
• Train, maintain and operate equipment.
• Basic technical knowledge and background.
• Participate/perform in tech transfer activities.
• Assist with validation execution.
• Received and organizes materials.
• Identify/communicate discrepancies of material deliveries.
• Use of support systems (SAP, Veeva, LIMs, etc).
• Understands concepts of manufacturing process and methods.
• Follows and understands GMPs.
• Revises and authors SOPs.
• Follows manufacturing batch records.
• Participate in technical document authoring.
• Use of basic Microsoft applications efficiently.
• Suggests continuous improvements.
• Some client interaction.
• Work with a cross-functional team of process development, engineering, MSAT, F&E, and quality teams.
• Cross trains in other areas and may be utilized to perform above job functions across the entire site.
• Performs under direct supervision

Education, Experience, and Qualifications

• H.S/Assoc with 2+ years of experience, or B.S (science preferred) with 0-2 years of experience.
• General knowledge of cGMP regulations.
• Experience working in a Biological Safety Cabinet (BSC).
• General knowledge of cell expansion vessels and purification equipment.
• Ability to work well independently and as part of a team.
• Exhibits attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows willingness to learn and problem-solve.
• Willingness to learn and operate production equipment.
• Able to adhere to all safety and company regulations.
• Able to accommodate a flexible work schedule to support business demands.