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Manufacturing Associate Ii
4 months ago
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 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).
**Responsibilities**:
- 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
- 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 mínimal 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
Qualifications:
- High School diploma and over 4 years of relevant experience
OR
- Associates’/Bachelor’s (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 company’s 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.
