Manufacturing Sciences & Technology Associate I

Bora Biologics USA•Rockville, MD

About The Position

The Manufacturing Technology Associate I provides technical support to biopharmaceutical drug substance manufacturing operations for MacroGenics’ late-stage clinical and commercial programs. The position will work in partnership with Manufacturing Operations and BioPharmaceutical Development to support technology transfers, process and equipment validations, and routine manufacturing at internal sites.

Requirements

Bachelor’s degree in Chemical / Biochemical Engineering, Biology, Chemistry, Biochemistry or related life sciences or engineering field
Academic, internship, co-op or professional exposure to biopharmaceutical manufacturing and/or protein purification processes, including column chromatography, titration and filtration (depth, membrane, ultrafiltration/diafiltration)
Experience with Deviation, CAPA and Change Control systems
Solid understanding of overall manufacturing process, and technical knowledge of downstream unit operations
Knowledge of current Good Manufacturing Practices and US/EU regulations
Ability to critically analyze data for process performance to compile technical reports and other documentation
Ability to collaborate with cross functional teams resulting in creative and positive outcomes
Strong verbal, presentation and writing skills to communicate effectively internally and externally
Excellent organizational skills, ability to prioritize multiple projects, and attention to detail
Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
Demonstrated ability to effectively present information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
Displays a clear willingness to listen to others
Solid proficiency in the use of Microsoft software (Word, Excel, PowerPoint)
Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment

Responsibilities

Leads investigations of deviations to determine root cause and product impact.
Develops recommendations and implements approved corrective action plans at cGMP manufacturing facilities.
Performs detailed data analyses and root cause analyses to identify solutions to complex problems.
Leads continuous process monitoring efforts and applies statistical tools to identify and improve productivity, efficiency, and robustness in manufacturing.
Actively engages in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites.
Supports continuous improvement and operational excellence methods and efforts to improve the overall productivity and efficiency of manufacturing operations.
Authors change controls, supports selection of new equipment and materials, and coordinates their implementation at manufacturing facilities to improve existing and new processes.
Supports technology transfer activities between internal and external manufacturing sites and corporate partners.
Supports fit-to-plant projections and plans for new processes and implements processes in multiple manufacturing facilities.
Collaborates with the Quality Assurance group to fulfill quality management goals and ensures the highest quality manufacturing processes.