Manufacturing Technician - II (Upstream / Downstream) - 12+ months

Lancesoft INC; Oceanside (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Lancesoft INC is seeking a skilled GMP manufacturing professional in Oceanside, CA to support viral vector manufacturing across downstream and upstream processes. You will ensure compliance with cGMP/GDP, operate MES/EBS systems, and collaborate with MSAT, Facilities, Engineering, and Quality teams.

The role requires hands-on experience in viral vector manufacturing, aseptic techniques, and the ability to work off-shifts and weekends, with a Bachelor’s degree in Biology or a related field

Qualifications

• Bachelor's degree in Biology or related field preferred or equivalent biotech/pharma manufacturing experience.
• Experience in biotech/pharma manufacturing is preferred.
• Willingness to work off-shifts and weekends.

Responsibilities

• Execute GMP manufacturing processes on the floor following batch records, SOPs, cGMP, GDP.
• Support right-first-time manufacturing and maintain a strong safety/compliance culture.
• Collaborate with MSAT, Facilities & Engineering, and Quality teams during GMP manufacturing runs.
• Perform raw material weighing and electronic inventory transactions using MES/EBS systems.
• Work with single-use systems, solution/buffer preparation, and filter integrity testing.
• Follow proper aseptic technique and cleanroom/laboratory practices.
• Assist with viral vector manufacturing, harvesting, and fill operations.
• Escalate process, equipment, and manufacturing issues appropriately.
• Assist with revisions of SOPs, Manufacturing Production Records (MPRs), and controlled documents.
• Review in-process GMP documentation for accuracy, completeness, and compliance.
• Work effectively in a cross-functional, team-based environment.
• Must be able to work off-shifts and weekends.

Skills

GMP compliance

Batch records

SOPs

cGMP

GDP

MSAT collaboration

Viral vector manufacturing

Education

Bachelor's degree in Biology or related field

Tools

MES

EBS

Single-use systems

Job description

Job Description

Job Description

Core JD – Common Requirements

• Execute GMP manufacturing processes on the manufacturing floor while following batch records, SOPs, cGMP, and GDP requirements .
• Support right-first-time manufacturing and maintain a strong safety/compliance culture.
• Collaborate with MSAT, Facilities & Engineering, and Quality teams during GMP manufacturing runs.
• Perform raw material weighing and electronic inventory transactions using MES/EBS systems.
• Work with single-use systems , solution/buffer preparation, and filter integrity testing.
• Follow proper aseptic technique and cleanroom/laboratory practices .
• Assist with viral vector manufacturing, harvesting, and fill operations .
• Escalate process, equipment, and manufacturing issues appropriately.
• Assist with revisions of SOPs, Manufacturing Production Records (MPRs), and controlled documents .
• Review in-process GMP documentation for accuracy, completeness, and compliance .
• Work effectively in a cross-functional, team-based environment .
• Must be able to work off-shifts and weekends .
• Bachelor’s degree in Biology or related scientific discipline preferred; equivalent biotech/pharma manufacturing experience may be considered.

Group 1 - Viral Vector (Downstream Processing)

• Experience with chromatography operations.
• Experience with Ultrafiltration/Diafiltration (UF/DF) .
• Experience supporting viral vector manufacturing using these downstream processing techniques.
• Experience with manual and/or automated fill of harvested viral vector material.
• Biopharmaceutical, cell therapy, or gene therapy manufacturing experience preferred.
• Strong knowledge of cGMP manufacturing practices .
• Ability to lift 40 lbs repeatedly and stand for extended periods.

Group 2 - Viral Vector (Upstream Processing)

• Hands-on mammalian cell culture experience.
• Experience maintaining cells in flasks, CellSTACK chambers, and single-use bioreactors .
• Experience with cell culture and filling unit operations .
• Experience with cell transfection and viral vector harvest .
• Experience with solution formulation and filter integrity testing.
• Prior cell/gene therapy or viral vector manufacturing experience strongly preferred.
• Experience working with single-use bioreactor systems is highly relevant.