Job Title: Manufacturing Associate - Biopharmaceuticals

Location: Rockville, MD

Type: 12 Month Contract potential for hire

Compensation: $32.00 - $40.00

Overview
Biopharmaceutical Company is seeking an experienced Manufacturing Associate to join their Downstream Processing team!

Responsibilities

• Participate in the manufacturing of biopharmaceutical drug products supporting multiple clinical programs, ensuring compliance with GMP regulations.
• Conduct purification operations including filtration, chromatography, titrations, column packing, and raw material accounting.
• Assist in creating and revising Batch Records, Work Instructions, Standard Operating Procedures, and Material Specifications.
• Document all manufacturing activities clearly and accurately in batch records, testing records, and laboratory notebooks.
• Maintain a clean and organized manufacturing environment, perform routine equipment maintenance, and ensure supplies are adequately stocked.
• Follow safety protocols when handling hazardous materials and maintain compliance with OSHA and GMP standards.
• Participate in projects aimed at improving efficiency and quality within the manufacturing team.
• Work collaboratively with quality assurance to meet quality management goals and support continuous process improvements.
• Operate bioprocess equipment such as single-use mixers, TOTE tanks, scales, and other manufacturing tools according to safety and regulatory guidelines.
• Engage in training and support of other manufacturing associates and technicians.
• Assist with deviations, CAPAs, change controls, and update production schedules in collaboration with relevant departments.

• High School Diploma or equivalent with exposure to science and math coursework and a minimum of three years of related experience in biotech/pharmaceutical industry OR Associate’s degree in a related discipline with no experience.
• Experience with aseptic techniques and GMP manufacturing is required if HSD; downstream processes like buffer prep, column packing, and purification are beneficial.
• Ability to self-motivate, driven, and capable of working independently in a fast-paced environment.
• Strong communication skills, both electronic and in-person, with the ability to collaborate effectively with team members.
• Experience with equipment operation, troubleshooting, and maintaining cGMP documentation.
• Pre-employment requirements include a 7-year background check, drug screening, education, and employment verification.
• Proficiency in using Excel, Word, PowerPoint, and document control systems.

System One, and its subsidiaries including Joulé 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.

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