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 Associate II is responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Understands aseptic technique concepts
Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
Able to operate and maintain equipment
Understands the basic operations and functions of equipment and is able to perform basic troubleshooting
Performs solution and material preparation
Possesses basic technical knowledge and background in the industry
Possesses basic and fundamental engineering and mechanical knowledge
Possesses basic and fundamental facility start-up experience
Has participated in facility start-ups
Participates on and performs technical transfer activities
Assists with the execution of validation activities
Receives and organizes materials
Performs material procurement activities
Identifies, communicates and resolves material discrepancies
Uses most support systems (e.g. LIMS) with some demonstrated proficiency
Understands the concept of and has performed or experience with manufacturing processes and methods
Identifies and understands acceptable and unacceptable practices and is able to make on the spot corrections to performance
Collects, records, reviews, performs basic analysis and identify basic trends of scientific and process data per good document practices
Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand why behind the regulations
Follows and executes Standard Operating Procedures (SOPs)
Revises and authors simple SOPs
Follows and executes Batch Records (BRs)

Revises and authors simple BRs
Trains others on basic SOPs, equipment and unit operations
Participates and provides information in the development of technical documents such as non-conforming events and deviations
Possess basic computer skills and able to efficiently use basic Microsoft applications
Suggests and participates in continuous improvement ideas
Identifies, participates and suggests solutions to technical problems
Identifies, suggests and seeks out for decision making
Participates and supports regulatory inspections and client audits
Interacts on a minimal basis 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 direct supervision and starts to work independently on basic tasks and processes

High School diploma and over 4 years of relevant experience

OR

Associates/Bachelors (science preferred) degree with over 2 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.
Based on work assignment, may be recommended to have medical testing in accordance with the companys Occupational Health Program.
Holiday and shift work often required based on manufacturing schedule as determined by Management.
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)

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.