Lead Bioprocess Associate-3rd Shift
About The Position
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 3rd shift operations, working Monday-Friday-10pm-6:30am. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Work under general supervision of Production Supervisor to manufacture parenteral drugs Perform compounding of pharmaceutical products following Production Batch Record Performs and documents developmental formulation batches as required. Responsible for performing bench-top, pilot, scale-up and verification batches. Edits/writes standard operating procedures as directed by the Production Supervisor Review and revise procedures and documentation to ensure cGMP compliance Maintains process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks. Performs or verifies calculations and measurements to ensure that batches made maintain consistent high-quality standards. Documents activity, as required, in batch records and log sheets. Assist the MS & T group, Validation and Engineering staffs 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 established company policies, SOP’s and Batch Record directions. Assist in clean room operations as needed. May be called upon to assist in general production activities when necessary. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Requirements
- BA/BS in any field Or High School/AA with at least three-years of experience in a manufacturing or laboratory setting
- cGMP
Responsibilities
- Work under general supervision of Production Supervisor to manufacture parenteral drugs
- Perform compounding of pharmaceutical products following Production Batch Record
- Performs and documents developmental formulation batches as required.
- Responsible for performing bench-top, pilot, scale-up and verification batches.
- Edits/writes standard operating procedures as directed by the Production Supervisor
- Review and revise procedures and documentation to ensure cGMP compliance
- Maintains process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks.
- Performs or verifies calculations and measurements to ensure that batches made maintain consistent high-quality standards.
- Documents activity, as required, in batch records and log sheets.
- Assist the MS & T group, Validation and Engineering staffs 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 established company policies, SOP’s and Batch Record directions.
- Assist in clean room operations as needed.
- May be called upon to assist in general production activities when necessary.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
