Upstream Manufacturing Associate

Bayside Solutions, South San Francisco CA


 

Upstream Manufacturing Associate

Reporting to the Manufacturing Supervisor, this role will be a contributing participant on the Upstream Process Science and Manufacturing team. The Manufacturing Associate will follow defined tasks in Upstream Manufacturing, cross train in Process Development, support process transfer into Manufacturing, effectively contributing to a team that is ultimately responsible for the processes and manufacturing. The Manufacturing Associate will be present in the production process, meet deadlines and be an active participant in issue reporting and resolution.

The specific responsibilities of this position include:

Perform all manufacturing operations under cGMP/ISO requirements
  • Adhere to valid manufacturing procedures and documentation
  • Collaborate with process development, support process development experiments
  • Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process
  • Contribute technical writing for SOPs and Batch Records
  • Maintain a high level of quality and compliance with regards to all aspects of manufacturing
  • Operate production equipment, including inspection, set up, processing, and cleaning
  • Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues
  • Identify and communicate issues to Manufacturing Supervisor and/or other manufacturing support personnel
  • Execute corrective measures addressing any issues in a timely manner
  • Contribute to process improvement plans and implementation of such plans
  • Other duties as assigned

Required Education, Skills and Experience
  • B.S. in Science or Engineering or equivalent experience such as 3 years' experience in the pharmaceutical or biotech industry, 1-2 years working in a GMP manufacturing environment in upstream operations
  • Strong communicator with ability to work independently and as part of a team
  • Experience in maintaining detailed records
  • Strong computer skills including MS Office (Word, Excel)
  • Effective problem solving skills

Preferred Skills and Experience
  • Technical understanding of a biotech manufacturing facility
  • Regulatory knowledge
  • Startup of a new facility
  • Experience with single use technologies such as bioreactors, welders, sealers
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