Manufacturing Associate I - Philadelphia, United States - WuXi AppTec

WuXi AppTec

Verified Company

Philadelphia, United States

2 hours ago

Posted by:

Mark Lane

beBee recruiter

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).

Responsibilities

Understands aseptic technique concepts
Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
Understands and is able to explain 'why' of acceptable and unacceptable aseptic technique practices
Trains others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting
Able to operate and maintain equipment
Understands the maintenance of equipment
Understands most operations and functions of equipment and is able to perform major troubleshooting
Identifies needs for corrective maintenance
Assists with sourcing and purchasing of standard equipment
Performs solution and material preparation
Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
Possesses basic and fundamental facility startup experience
Has participated in facility startups and may participate on a subteam to support
Participates on and performs technical transfer activities
Provides feedback for facility fit
Executes validation activities
Provides input and reviews validation documentation
Scheduled, receives and organizes materials
Performs material procurement activities
Creates and revises material documents
Creates CS forms
Identifies, communicates and resolves material discrepancies
Understands the concept of and has performed or experience with manufacturing processes and methods
Trains others on basic operations such as media preparation, thaw, passage and harvesting
Identifies, understands and able to explain the 'why' of acceptable and unacceptable practices, is able to make on the spot corrections to performance
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. Able to coach and mentor others to do the same
Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
Follows, executes, authors, and improves the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
Trains others on SOPs, equipment and all unit operations
Participates, provides information in the development of and authors basic technical documents such as nonconforming events and deviations
Suggests, participates and implements continuous improvement ideas
Identifies, participates and suggests solutions to technical problems
Identifies, suggests with options and seeks out for decision making
Starts to delegate work assignments
Participates, supports and assists as an SME during regulatory inspections and client audits
Interacts on an occasional basis with groups that support manufacturing
Starts to coordinate internally and deal with problems with groups that support manufacturing
Performs well under direct supervision and works independently on basic tasks and processes

Qualifications

High School diploma and 1 year of relevant experience or
Associates'/Bachelor's (science preferred) degree with over 3 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.

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