Senior Manufacturing Associate

3 days ago


Philadelphia, Pennsylvania, United States WuXi AppTec Full time

Job Summary

We are seeking a highly skilled and detail-oriented Senior Manufacturing Associate to join our team at WuXi AppTec. As a key member of our manufacturing team, you will be responsible for the manufacture of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities

  • Understand and apply aseptic technique concepts to ensure the quality and safety of our products.
  • Perform and troubleshoot equipment operations, maintenance, and troubleshooting to ensure efficient and effective manufacturing processes.
  • Train and mentor colleagues on basic aseptic operational techniques, such as media preparation, thaw, passage, and harvesting.
  • Participate in facility start-ups, technical transfer activities, and validation activities to ensure compliance with cGMPs.
  • Collaborate with internal and external stakeholders to communicate scientific and process data and recommend paths for forward processing.
  • Follow compliance and regulatory requirements, current Good Manufacturing Practices (cGMPs), and understand the 'why' behind the regulations.
  • Identify, communicate, address, and improve simple cGMP compliance and regulatory gaps and issues.
  • Participate in the development of and author basic technical documents, such as non-conforming events and deviations.

Qualifications

  • High School diploma and over 6 years of relevant experience or Associates'/Bachelor's (science preferred) degree with over 3 years of relevant or equivalent experience.
  • Ability to accurately and reproducibly perform arithmetic calculations, including fractions, decimals, and percentages, and basic algebraic and geometric calculations.
  • Proficient in Oral & Written communication skills, Microsoft (Excel, Word, Outlook), and able to read, write, and understand English.

About WuXi AppTec

We are a global contract research organization (CRO) that provides a comprehensive range of services to support the discovery, development, and manufacturing of small molecule, biologic, and cell and gene therapies. Our values include Integrity & Dedication, Working Together & Sharing Success, and Doing the Right Thing & Doing it Right.

We are committed to providing opportunities for internal growth and development, with direct access to a dedicated and accessible Human Resources team. We provide 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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