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Manufacturing Operations Coordinator

3 months ago

Philadelphia, United States Wapt Full time

Overview:
**WuXi Advanced Therapies** is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.

Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

Our benefits include:

- 401K matching
- PTO
- Employee discount programs
- Medical, dental and vision insurance
- and much more

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
- 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 mínimal 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 basi