Downstream Manufacturing Associate

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. The Lead BPA is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.  The schedule for this position is 2nd Shift, 8 Hours, Mon-Fri. 

2. ESSENTIAL FUNCTIONS

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

• Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
• Demonstrates, understands and adheres to policies, GMP standards and safety procedures
• Troubleshoot, advanced maintenance and repair activities on equipment and systems used in Manufacturing according to Standard Operating Procedures (SOPs) 
• Perform and monitor critical processes, execute routine validation protocols, work orders 
• Informs supervisor/ manager on progress of projects, transfer of data, process details, etc.
• Executes batch records according to GMP and site quality standards
• Generates Batch Records, SOPs and Protocols as required
• Responds to off-hour alarms as assigned by supervisor/ manager
• Executes manufacturing cleanroom changeover and activation
• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
• Supports QA during audits and regulatory inspections
• Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

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

• HS diploma with 7 or more years’ experience with production processes under GMP compliance OR 
• Associate degree in a Scientific, Engineering or Biotech field with 5 years’ experience with or biologic production processes under GMP compliance OR 
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 2-3 years’ experience with biologic production processes under GMP compliance 
• 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, deviation & summary reports