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Manufacturing Operations Coordinator

1 month ago

Philadelphia, United States WuXi AppTec 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

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.

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec 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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We can recommend jobs specifically for you 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 (

Job Locations US-PA-Philadelphia

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