**Overview**

Responsible for providing support in performance of activities within production facilities to 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**

• Understands aseptic technique concepts and has performed aseptic technique.

• Is able to identify unacceptable practices, make spot corrections to performance and implement improvements

• Understands and is able to explain 'why' of acceptable and unacceptable aseptic technique practices

• Supports design of aseptic operational techniques such as media preparation, thaw, passage, harvesting and overall systems and operations

• Identifies, participates, suggests solutions and leads complex technical problem solving

• Understands and teaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting

• Able to operate and maintain equipment and coordinate complex corrective maintenance

• Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues

• Drives sourcing and purchasing of standard, new and complex equipment

• Primary point of escalation for equipment issues

• Trains others performing solution and material preparation, analyzing results and resolving issues

• Reviews solution and material preparation results and resolves issues

• Primary point of escalation for solution and material preparation issues

• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

• Trains others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding

• Trains others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding

• Possesses basic and fundamental facility start-up experience and trains others on facility start-up

• Has participated in facility start-ups and may lead a sub team that requires leading, planning, coordinate, delegate and manage across assigned programs

• Provides input into facility design and provides feedback for facility fit

• Leads, participates on and performs technical transfer activities while training others and managing performance

• Coordinates resources to support technical transfer runs and reviews protocols and other technical transfer documents

• Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer

• Executes in-house and offsite validation activities and trains and manages the performance of validation activities

• Has working knowledge of validation requirements and provides input, reviews and executes validation documents

• Identifies validation gaps and needs across assigned programs

• Supports performance of scheduling, receipt and organization of materials and forecast and supports material procurement activities

• Reviews and finalizes material documents, creates and/or approves CS forms and owns change controls

• Uses all support systems (e.g. LIMS) with demonstrated proficiency and is able to act as subject matter expert (SME) and/or Superuser on a system and train others

• Acts a lead, member or Champion that helps to design the new system or of a systems improvement team

• Understands the concept of and has performed or experience with manufacturing processes and methods, interprets data and draws conclusions

• Supports overall performance of manufacturing processes and methods ensuring compliance with standards

• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific

• Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices

• Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing

• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands 'why' behind the regulations.

• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific

**Qualifications**

• HS Diploma or equivalent required, BS/BA in Science related field preferred; or a combination of relevant Experience & Education

• 5+ years of relevant technical experience with a minimum of 2 years in a Lead/Leadership/Supervisory role

**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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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 ([ Link removed ] - Click here to apply to Senior Bioprocessing Associate />
**Job Locations** _US-PA-Philadelphia_

**Job ID** _2022-10379_