Title: Manufacturing Associate II/III
Location: Rockville, MD
Type: 12+ Month Contract potential for extension or hire
Start Date: Immediate

Overview: 
The Manufacturing Associate II/III participates in the cell culture manufacturing of biopharmaceutical drug substance to support multiple clinical programs. This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) to ensure that materials manufactured meet required specifications and regulatory requirements.

Responsibilities 

• Operate expansion and production reactors, conduct harvest operations, and order and account for consumption of raw materials and components. Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.
• Assist in the preparation and maintenance of reports and other documentation as applicable to the scope of operations in the manufacturing facility.
• Work in collaboration with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.
• Plan for raw material requirements by maintaining appropriate inventory of chemicals/consumables and ordering them as needed.
• Coordinate sample testing and room release with QC.
• Assist with technical issues and problems.
• Assist with scale-up and basic trouble-shooting of technical issues and other problems encountered within the manufacturing process.
• Monitor, maintain and calibrate laboratory equipment as needed.
• Monitor and audit work processes to ensure compliance and completion of targets.
• Prepare and revise batch records and SOPs, as well as drafting of technical reports.
• Write deviation/incident reports as needed.
• Identify areas for improvement in manufacturing efficiencies and compliance.
• Assist with technology transfer from Process Development to manufacturing environment.
• Prepare (wipe down) equipment for use in cleanroom environment. Maintain working inventories of supplies within the production area.
• Perform media preparation, buffer preparation, cell culture, and filtration processing steps.
• Organize projects and data using Excel, Word, PowerPoint and a document control system.
• Maintain a clean and safe plant environment.

Qualifications

Education & Experience

Manufacturing Associate II

• High School Diploma or equivalent and a minimum of five years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or Associate’s degree in a related discipline and a minimum of one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• Prior experience following GMP rules and procedures

Manufacturing Associate III

• High School Diploma or equivalent and a minimum of seven years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or
• Associate’s degree in a related discipline and a minimum of three year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• Prior experience following GMP rules and procedures

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.