1. JOB SUMMARY

The Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This role is r esponsible for preparing tubing, equipment, supplies, and other items associated with sterile filling processes as well as routine tasks in the production of drug product for Phase I/II & commercial GMP manufacturing, including setup and operation of equipment and processes associated with sterile filling processes and daily cleaning and sanitization activities throughout the production area .

T his position is 2nd Shift 2PM – 10:30PM

1. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Work under general supervision of more experienced Technicians or Manufacturing Supervisor to produce parenteral drugs
• Comply with cGMP regulations, adhere to EBSI policies, and adhere to EBSI SOP and Batch Record directions.
• Complete all necessary documentation in a manner that complies with Good Documentation Practices (GDP) as tasks are performed.
• Independently setup, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the sterile core, in accordance with current industry, client and EBSI standards.
• Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
• Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
• Conduct training sessions for less experienced associates to ensure a high level of effectiveness and quality is met during production operations.
• 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.
• Maintain proper Gowning Qualifications necessary for routine aseptic operations, including filling operations and cleaning.

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.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 2-3 years’ experience in GMP environment
• HS diploma with 7 or more years’ experience in GMP environment
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, and deviations