Companies you'll love to work for

Job Description

General Summary:

The Manufacturing Operations Specialist will assist in the day-to-day manufacturing operations at the Leiden Center 1 (LC1) facility. Under supervision, the incumbent will be working in the Drug Production facility performing the set-up, operation and disassembly of Clinical Products. The incumbent will work in collaboration with drug product development teams through all phases of development, process validation and commercialization to understand process requirements and provide feedback on process performance. This role is for 2nd Shift (2PM - 8PM)

Key Duties and Responsibilities:

• Follow strict adherence to cGMP requirements including:
• Compliance with all on-going training requirements
• Following SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility
• Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility
• Execute and witness batch record instructions during cGMP operations
• Interface with cleaning staff, and Facilities/Operations to make sure the facility meets its intended use requirements as well as to schedule routine cleaning and all the necessary calibration and preventive maintenance activities
• Interface with all appropriate key stakeholders, such as Quality and EH&S to ensure appropriate procedures are followed to ensure successful operation of the drug product facility
• Interface with Materials Management and the Release and Stability Laboratory to coordinate the purchase and delivery of necessary materials and the testing of routine cleaning and release samples.

Knowledge and Skills:

• Ability to follow verbal and written instructions
• Good communication and documentation skills.
• Ability to work in a multi-disciplinary, collaborative manufacturing team with well-defined deliverables
• Basic computer skills and demonstrated ability to learn new systems and understand new technologies
• Experience with manufacturing systems utilizing computerized control systems and HMIs
• Basic understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment

Education and Experience:

• Bachelor's degree in a scientific or technical discipline
• 2 years of experience or the equivalent combination of education and experience related to GMP manufacturing

Company Information