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Manufacturing Supervisor

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 07/27/2018 Job Type: Scientific Job Number: JN -072018-22153
Manufacturing Organization supports the Technical Operations (TechOps) business by compliantly & successfully producing antigen-based products in line with commercial cGMPs.
  • Main responsibility to lead & oversee all functional activities associated with manufacturing operations in a multi-product GMP facility.
  • Collaborate with cross functional partners such as QA, QC, Supply Chain, Manufacturing Science & Technology, Engineering, & Validation to accomplish organizational objectives.
  • May work in any one of the following Manufacturing departments: Fermentation, Purification, Bulk Fill, Peptide Synthesis, or Technical Services.
  • Ensure safe & compliant production of commercial antigens including purification & analytical testing stages.
  • Responsible for all regulatory compliance activities & assures group compliance to cGMP & regulatory requirements through monitoring, trending, & auditing. Ensure safety & compliance regulations are enforced.
  • Follow valid manufacturing procedures & documentation. Ensure batch records, logbooks, inventory forms, in-process data spreadsheets, & associated attachments are completed in a timely manner & accurately.
  • Ensure applicable Change Control policies & procedures are followed for new or modifications to existing facility, equipment, processes.
  • Assist in the investigation of deviations in a timely manner to identify root causes of problems & implement appropriate corrective actions to prevent from reoccurrence.
  • Analyze production processes & environment to identify opportunities for continuous improvement & develop a culture of operational excellence.
  • Develop & draft new Standard Operating Procedures (SOPs), modify or eliminate outdated/ineffective SOPs when appropriate.
  • Ensure SAP transactions are being performed per agreed timeframes for different stages in the manufacturing process.
  • Assist in the training & development of personnel as well as evaluate the effectiveness of training & set individual & group goals.
  • Manage group budget.
  • Lead special projects as needed.
  • Must have in-depth knowledge of commercial manufacturing. Downstream Preferred.
  • Must have a thorough understanding of cGMPs.
  • Must be creative, highly organized, self-motivated, perceptive, & innovative.
  • Must have strong written & verbal communication skills.
  • Must be able to manage a diverse group of people with different strengths & skills.
  • Must have highly developed individual management skills as well as team performance management skills.
  • Must be able to handle multiple priorities & delegate responsibilities while maintaining quality.
  • Must have excellent team building & project management skills
  • Lean, 5S, & Operational Excellence a plus.
  • SAP including cycle counting & inventory reconciliation skills a plus.
  • Must have experience drafting & revising SOPs & batch production records.
  • Must be proficient using MS Outlook, Word, Excel, & PowerPoint.

NOTE: The applicant must be flexible & willing to work evenings, weekends, & holidays based on the production schedule needs.
  • BA/BS degree in chemistry, biology, or related field.
  • Actual cGMP Manufacturing experience will be considered.
  • Minimum of 6+ years of GMP experience including 2+ years of supervisory or team leadership experience.

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