Manufacturing Associate II

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)

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

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)

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 or

equivalent experience

Masters with 0+yrs of industry experience

Hands on mammalian cell culture experience is a MUST

Experience 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.