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 read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
Physical Requirements:
Must be able to work in an office environment with minimal noise conditions.
Must be able to work in Lab setting with Biohazards /various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to stand /Sit/walk for long periods of time
Ability to Lift 40 lbs routinely
Ability to crouch, bend, twist, and reach
Ability to push/pull 40 lbs routinely/ often / occasionally
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
Inside/outside working conditions
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
Advanced Therapies, LLC provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in_iframe=1&hashed=-435740542)
Job Locations US-PA-Philadelphia
Job ID 2025-13656
