Mammalian Cell Culture - Philadelphia, United States - Blue Ocean

Blue Ocean

Verified Company

Philadelphia, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Overview:

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 startup experience
Has participated in facility startups
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 nonconforming 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