Manufacturing Associate

Overview

Support cGMP manufacturing of plasmids, viral vectors, and cell therapies in a clinical site.

Key Responsibilities

• equipment maintenance
• calibration
• gmp documentation
• visual inspection
• inventory management
• cleanroom ops

Tasks

-Maintain appropriate level of training for assigned responsibilities. -Adhere to the current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs). -Identify opportunities for continuous improvement. -Support a culture of safety and GMP compliance. -Complete and review GMP documentation in a timely manner. -Assist with daily tasks and support manufacturing. Collaborate Effectively -Support operational excellence initiatives. -Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable. -Maintain production facilities at a high standard of cleanliness and organization. -Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients. -Perform equipment maintenance and calibrations as required. -Escalate manufacturing operations issues to management and quality assurance in a timely manner. -Assist with inventory management of supplies in the manufacturing facility. -Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns.

Requirements

• cgmp
• mes
• erp
• 4 years
• cell therapy
• quality systems

What You Bring

-Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time. -Experience with electronic systems such as MES and ERP. -A Minimum of 4 years’ experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation. -Demonstrate technical acumen, operational understanding, and GMP compliance. -Experience with quality management systems (e.g. Deviations, CAPAs, Change Management). -Be a team player, offer assistance, and respond well to requests for help from team members. -Use strong communication and build relationships. -Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies. -Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.

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Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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