CMC OPERATOR (Computerized Machining Center)
Loading materials, calibrating equipment, and monitoring the operation to ensure quality parts are produced according to specifications.
Key Responsibilities:
Machine Operation and Setup: Prepare and operate CNC machines to perform tasks such as drilling, cutting, and shaping various materials. This includes loading raw materials and parts onto the machines.
Blueprint and Drawing Interpretation: Read and interpret technical documents, blueprints, and mechanical drawings to understand task specifications and desired results.
Programming: Translate instructions into computer commands (often using G-code and M-code) so the machines can perform the correct functions. In some roles, this may involve loading pre-written programs and making minor adjustments.
Quality Control: Supervise the machines during production and perform test runs to ensure outputs meet specifications
Maintenance and Troubleshooting: Conduct regular, preventive maintenance and cleaning of the machinery to ensure optimal functionality and prevent breakdowns.
Safety and Documentation: Adhere to all safety protocols and guidelines, including wearing appropriate personal protective equipment (PPE).
EXPERIENCE CANDIDATES RESPONSIBILITY
Manage CMC development: Lead CMC development plans for drug substances and products from early research through commercialization.
Oversee vendors: Maintain and enrich relationships with third-party contract manufacturers and analytical labs.
Ensure regulatory compliance: Guarantee CMC activities, including those with external parties, adhere to company policies and regulations.
Prepare and review submissions: Author and review CMC sections for regulatory submissions (IND, NDA, BLA, MAA) and ensure they meet high-quality standards and timelines.
Support project teams: Serve as the CMC subject matter expert for internal and external cross-functional project teams.
Ensure quality and compliance: Oversee compliance with GMP and other regulatory requirements.
Manage change and technology transfer: Coordinate and manage change controls and technology transfer processes.