Assistant Process Engineer - Cell Therapy Raw Materials

We are looking for a Associate Engineer to join the raw materials team within the CTTO ( Cell Therapy Technical Operations ) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production.

Responsibilities include, but are not limited to, the following :

• Support as a SME for raw materials including single-use systems (SUS) and material sciences.
• Provide technical support on in CAR-T commercial manufacturing.
• Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications.
• Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials.
• Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes.
• Vendor management including change controls, audits, deviations, and QRM programs.
• Support investigations and ensure compliance with internal standards and requirements.
• Perform technical diligence visits to raw material supplier sites with cross-functional teams.
• Provide necessary technical analysis to support impact assessments and investigations.
• Support responses for Information Request (IR) from regulatory bodies.

Requirements

Prerequisites :

Additional Skills :

Benefits

Competitive hourly rate : $28.78 – $35.11 / hr (W-2 only, no C2C)

Working Hours : Monday - Friday, regular business hours

6-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits

Employee referral bonus program