Manufacturing Technician - II

Lancesoft; Oceanside (CA); On-site; USD 45,000 - 65,000; Full time

Job summary

Lancesoft is seeking an on-site manufacturing professional in Oceanside, California to execute GMP processes and support viral vector production. The role requires adherence to batch records, SOPs and cGMP standards under supervision.

Responsibilities include weighing materials, MES/EBS transactions, and collaboration with MSAT, Facilities, Engineering and Quality. Weekend and off-shift work may be required as part of the role.

Qualifications

• Experience following batch records, SOPs and cGMP regulations.

Responsibilities

• Execute manufacturing processes on the floor under supervision, following batch records, SOPs and cGMP regulations.
• Ensure right-the-first-time performance of process steps and support safety culture.
• Collaborate with MSAT, F&E and Quality to run GMP operations.
• Weigh raw materials and perform MES and EBS transactions under supervision.
• Perform cell culture and filling unit operations for viral vector production in a cGMP environment.

Tools

MES

EBS

Job description

Onsite Position - 5 days/week 1st start date: 11/16 2nd start date: 12/15 Duration: 1 year

Responsibilities

• Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
• Ensure right-the-first-time performance of all process steps specific to the phase or stage of operation, as well as help drive the safety-first culture.
• Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
• Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
• Under supervision, perform cell culture and filling unit operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper laboratory etiquette, Good Documentation Practices (GDP), and sound scientific methods.
• Prepare and use single use systems to support solution formulation and filter integrity testing.
• Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems.
• Assist with transfection of cells and harvest of viral vectors.
• Assist with manual and/or automated fill of harvested viral vector material.
• Escalate processing and equipment issues as needed.
• Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
• Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend.
• Additional duties as assigned.