Manufacturing Operations Coordinator

Overview

The Manufacturing Operations Coordinator is responsible for coordinating manufacturing activities for those who produce and support the manufacture of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities

• Plans, coordinates, tracks, communicates, follows-up and reports out on the use, cleaning, preventative maintenance, corrective maintenance and calibration requirements while working with Manufacturing, Facilities, Metrology and vendors
• Assists with sourcing and purchasing of equipment
• Plans, coordinates, tracks, communicates, follows-up and reports out on solution and material preparation
• Possesses basic industry knowledge, ideally background in the pharmaceutical and biotechnology industry or cell and gene therapy
• Possesses basic and fundamental engineering and mechanical knowledge
• Plans, coordinates, tracks, communicates, follows-up and reports out on facility activities including start-up
• Possesses basic and fundamental understanding of technical transfer activities
• Helps coordinates resources for and plans, coordinates, tracks, communicates, follows-up and reports out on technical transfer progress as it relates to manufacturing area readiness
• Plans, coordinates, tracks, communicates, follows-up and reports out on validation activities
• Plans, forecasts, coordinates, tracks, communicates, follows-up and reports out on orders, receipts, documents and procurement of materials, material discrepancies and material related activities while working with Supply Chain
• First point of escalation for material related issues
• Proficiency on Great Plains
• Possesses basic and fundamental understanding of support systems (e.g. LIMS)
• Understands the concept of manufacturing processes and methods
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.
• Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
• Follows and executes Standard Operating Procedures (SOPs)
• Tracks, communicates, follows up on and reports out the status of SOPs
• Tracks, communicates, follows up on and reports out the status of Batch Records (BRs)
• Compiles, prepares and presents metrics/KPIs
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates and implements continuous improvement ideas
• Plans, forecasts, models, coordinates, tracks, communicates, follows-up and reports out on work assignments
• Plans, coordinates, tracks, communicates, follows-up and reports out on regulatory inspections and client audits
• Interacts frequently with groups
• Regularly and frequently coordinates with groups
• Identifies and works to resolve issues and relations with groups that support manufacturing
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under minimal supervision and starts to work independently on basic tasks and processe
• Identifies and prioritizes escalations
• Has basic financial knowledge and acumen
• Forecasts and models financials
• May be required to work Holidays and weekends
• May be required to work Overtime
• May be required to work outside of normal business hours
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments

Qualifications

Experience/Education:

• High School diploma and over 6 years of relevant experience or
• Associates’/Bachelor’s (ideally science) degree with over 3 years of relevant or equivalent experience

Knowledge/Skills/Abilities:

• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• Proficient in Oral & Written communication skills
• Need to be able to rea