Lead Bioprocess Associate - 2nd - Shift

Bora Pharmaceuticals•Baltimore, MD

32d•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summary Responsible for the manufacture of biopharmaceuticals, including bench top, scale up and pilot formulations; preparing and operating process equipment, handling materials, dispensing chemicals and interfacing with Maintenance, QA, QC and Tech Group in a cGMP environment. This position will support 2nd shift operations, working Monday-Friday-2pm-10:30pm.

Requirements

1-3 years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing.
Thorough knowledge of current Good Manufacturing Practices (GMP)
The ability to work cross-functionally with multiple departments and excellent oral and written communication skills are required.
Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
Excellent documentation skills including comprehension, review and establishing Batch Production Records, SOP’s, deviation & summary reports

Nice To Haves

Certificate, Diploma, Degree or equivalent in Science, Engineering or related field preferred.

Responsibilities

Work under general supervision of Manufacturing Supervisor to produce parenteral drugs
Perform compounding of pharmaceutical products following Production Batch Record.
Perform and document developmental formulation batches as required.
Responsible for performing bench-top, pilot, scale-up and verification batches.
Maintain process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks.
Perform or verify calculations and measurements to ensure that batches made maintain consistent high-quality standards.
Document activity, as required, in batch records and logbooks.
Assist the Technical Transfer Group, Validation, and Engineering departments with the operation and execution of engineering projects.
Interface with the Quality Assurance, Quality Control, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues.
Assist with the preparation of materials needed for Formulation.
Comply with cGMP regulations; adhere to Bora’s policies, SOP’s and Batch Record directions.