Manufacturing Associate II

JOB DESCRIPTION

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).

Essential Job Functions:

• 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

• 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

• Potential to be selected for Visual Inspection Qualification. Selected individuals are required to inspect final product in a light booth to detect defects and record the pass/fail results of their inspection.

Job Requirements:

Experience / Education

• 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.

JOB DESCRIPTION

Revision Date: 20JAN23

• 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)

Compensation:

$21.67-$28.06

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.