Description:

The candidate will help the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will follow Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture). These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors, and conducting large scale filtration or centrifugation.

A day in the Life:

• Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.

• Assist in all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.

• Documentation of all activities to meet cGMP requirements. Complete document reviews and revisions. Daily record review, tasks, and databases. Participate/Lead in shift exchanges, 1-1’s, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities).

• Support a quality investigation by answering questions and making suggestions for improvement.

• Practices and promotes safe work habits and adheres to safety procedures and guidelines.

• Critical evaluation of processes, including foresight and thinking ahead.

• Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly.

Skills:

Gmp, Cleanroom, aseptic technique, Cgmp, Aseptic, Pharmaceutical, Pharmaceutical industry, Purification, Filtration

Top Skills Details:

Gmp,Cleanroom,aseptic technique,Cgmp,Aseptic

Additional Skills & Qualifications:

Education:

• HS Diploma or equivalent required

Experience:

• Required: Minimum of 2 years of work experience in manufacturing, operation, production, lab setting or related field

• Preferred: Experience in a cGMP environment

Knowledge

• Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred

• Subject Matter Expert on upstream processing steps- preferred

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.