What are the responsibilities and job description for the Senior Manufacturing Associate position at Actalent?
Top Skills' Details:
GMP, Aseptic Technique, Bio Certificate, Associates
Description:
Must Have's
Experience working in GMP environment (2 years)
Experience working in a lab environment
Biotech Certificate (minimum)
Manual Cell Culture experience
Manufacturing of cell therapy products.
Position Summary:
Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Day to Day Responsibilities
Core Responsibilities:
• Master core responsibilities of Sr. Manufacturing Tech
• Effectively write and investigate deviations in TrackWise.
• Able to train in the role of an On the Job Trainer and become a Qualified Trainer.
• Able to make culture decisions based on cell observations.
• Perform transactions in ERP system.
• In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Preactor, TeamShare, QT.
• Other duties as assigned.
Preferred Qualifications:
• Experience in small scale tissue culture processing.
• Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO.
Additional Skills & Qualifications:
Basic Qualifications:
• Biotechnology certificate with 4 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or 6 years of cGMP experience with GED or equivalent.
• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 2 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.
Work Environment:
Candidates will be on their feet for 6 hours a day culturing cells and the other 2 hours will be related to documentation.
Schedule:
- Sunday - Wednesday (7am - 5pm or 8am - 6pm)
- Wednesday - Saturday (7am - 5pm or 8am - 6pm)
There are two openings ranging from Associate I to Associate II. Main difference between the two are years of experience.
Associate I (Biotech Cert & 4 yrs GMP experience OR BA and 2 yrs GMP)
Associate II (Biotech Cert & 6 yrs GMP experience OR BA and 4 yrs GMP)
Cell Culture is a MUST HAVE
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
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.