Assistant Process Engineer

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

• 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.

Education and Experience:

• B.S. with 0+ years of experience or M.S. with 0+ years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent.
• Experience with Quality Management System (Ex. Deviation, CAPA, Change Management).
• Experience in Single Use Systems, GMP experience, Data Management.

Knowledge, Skills and Abilities:

• Exposure to raw materials (both liquid and single use system).
• Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing.
• Experience working with vendors and contract manufacturing sites.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Data management skills and comprehension skills of technical documents, such as process description documents.
• Ability to assess risk and develop contingency plans for process risks.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.
• Knowledge of GMP manufacturing practices and documentation requirements.

Additional Skills:

• Understanding of key considerations for single-use containers used for raw materials.
• Familiarity with raw material supply chains and manufacturing methods.
• Data management and grasp apprehension of technical instructions
• Lean Manufacturing experience is desired.