Manufacturing Associate I – Production Support

Bora Pharmaceuticals•Rockville, MD

7d•$60,000 - $62,000

About The Position

The Manufacturing Associate I supports the production of biopharmaceutical drug products for multiple clinical programs in the Production Support area. The role works in a GMP manufacturing suite to prepare materials for manufacturing processes and ensure compliance with applicable specifications, regulations, and procedures. The position performs support activities such as planning and communicating material needs, weighing materials, preparing and testing solutions, coordinating sample collection and submission, cleaning facilities and equipment, ordering materials, and recording raw-material and component transactions in an electronic management system. It creates and revises GMP documents, maintains inventory and equipment, documents manufacturing activities, and collaborates with Quality Assurance. The role also operates bioprocess equipment and participates in projects to improve production support services, quality, and efficiency. The listed salary range is $60,000–$62,000. Bora offers a benefits package that includes health coverage, retirement savings with employer matching, paid time off, professional development, wellness programs, employee assistance, and mental health resources.

Requirements

High school diploma or equivalent, including exposure to science and math coursework, and at least two years of related biopharmaceutical manufacturing experience in an FDA-regulated, controlled production environment; or an associate’s degree and one year of such experience; or a bachelor’s degree in a related discipline with no experience.
Knowledge of basic chemistry.
Ability to write and revise technical documents clearly and concisely.
Technical accuracy and ability to perform mathematical calculations.
Ability to follow detailed instructions and maintain accurate records and notes.
Strong organizational skills and attention to detail.
Ability to work effectively in a team and demonstrate commitment to generating quality products.
Professional work ethic driven by manufacturing timelines and commitment to continuous improvement.
Ability to think critically, analyze data, and respond quickly while managing multiple manufacturing projects.
Problem-solving and troubleshooting skills.
Ability to safely operate production equipment according to established practices.
Ability to lift up to 30 lbs.
Ability to work occasional weekends or overtime as needed.

Responsibilities

Perform support tasks for clinical-trial manufacturing in a GMP environment, including planning and communicating daily material needs, weighing materials, preparing and testing solutions, coordinating sample collection and submission, cleaning facilities and equipment, ordering materials, and recording routine raw-material and component transactions in the electronic management system.
Create and revise Solution Records, Work Instructions, Standard Operating Procedures, and other GMP documents related to support work.
Review cleaning logbook forms for accuracy.
Clean and disinfect materials entering the manufacturing suite.
Prepare solutions, complete and review solution records under GMP regulations and related SOPs, and accurately document manufacturing, testing, preparation, and equipment-use activities.
Collaborate with Quality Assurance to fulfill quality management goals and support high-quality manufacturing processes.
Maintain chemical and supply inventory, perform routine equipment maintenance and housekeeping, and ensure equipment and materials are available and adequate.
Participate in assigned projects to improve production support service, quality, and efficiency.
Operate bioprocess equipment, including single-use mixers, TOTE tanks, mixers, and scales, in accordance with cGMP, OSHA, policies, and regulations.
Follow safety rules and procedures when working with hazardous materials.
Organize projects and data using Excel, Word, PowerPoint, and a document control system.
Request Master Batch Records from Quality Assurance Document Control.
Perform other activities assigned by the area supervisor.