Fermentation Specialist - Manufacturing Sciences in Emeryville, CA at Apex Life Sciences

Date Posted: 2/9/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Fermentation Specialist for an exciting project focused on the clinical manufacturing of new recombinant proteins. 

Duties:

  • Provide front-line technical support and act as the primary support for tech transfer activities of new processes/products into Manufacturing.
  • Support production efforts through advanced activities such as running process equipment, trouble shooting processes, and document revision.
  • Support process technology transfers from other departments into Manufacturing.
  • Participate in high level department projects & initiatives designed to improve operational capabilities.
  • Provide technical troubleshooting support in the event of an issue.
  • Author & revise applicable department documentation including Batch Production Documents (BPDs) & Standard Operating Procedures (SOPs).
  • Analyze operational data & utilize statistical process monitoring tools to reduce process variability.
  • Assist department staff with production support activities including pre-production checks & equipment testing activities as required.


Skills:

  • BS in Biological Sciences, Physical Sciences, or Engineering required; Masters degree a plus
  • 3 years experience in a regulated biotechnology / medical device industry desired
  • Exposure to SAP and Fermentation automation systems (MFCS or equivalent) is a significant plus
  • 5S, OpEx & Lean manufacturing experience a plus
  • Must have strong technical knowledge of and exposure to biotechnology processing unit operations especially in microbial fermentation and product separation.
  • Must have thorough knowledge and application of cGMPs including equipment & technology
  • Established troubleshooting abilities including process monitoring
  • Strong interpersonal & cross-functional team building skills
  • Excellent communication skills, organizational skills, keen observation, writing and problem solving skills
  • Must be able to work independently and as well as in team settings with the ability to prioritize & complete activities on time
  • Must be able to establish & maintain effective working relationships with cross-functional stakeholders & co-workers
  • Microsoft Word and Excel experience required

***For immediate consideration, please email your updated resume to Ljohnson@apexlifesciences.com with 'Fermentation Specialist' in the subject line.