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Description:
: Responsible for manufacture of Master and Working Cell Banks andperforming activities within production facilities to support manufacture of Cell &Gene Therapy products, and final product fills according to current GoodManufacturing Practices (cGMPs)Understands aseptic technique concepts Has performed aseptic technique, is able to identify unacceptable practices andmake spot corrections to performance Able to operate and maintain equipment Understands the basic operations and functions of equipment and is able toperform 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 activitiesFollows compliance and regulatory requirements and current Good ManufacturingPractices (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)
Skills:
biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream
Top Skills Details:
biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream
Additional Skills & Qualifications:
Associates’/Bachelor’s (science preferred) degree with over 2 years of relevant orequivalent experienceMasters with 0+yrs of industry experienceHands on mammalian cell culture experience is a MUSTExperience working within a Bio Safety Cabinet is a MUST Experience in aseptic processing techniques and some understanding of regulatory requirements for a cGMP manufacturing facility
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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