Oakland-Fremont-Pleasanton Metro Area, CA
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- Develop & draft new Standard Operating Procedures (SOPs), modify or eliminate outdated/ineffective SOPs when appropriate.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.