Location/Division Specific Information

US - Fremont, CA

SDG, CDD

How will you make an impact?

The Scientist III, Formulations is responsible for manufacturing products for the Bulk Formulations team and completes associated cGMP documentations. Works with chemicals and biologics to manufacture reagents, calibrators and controls for IVD use. Leading teamates and resolving day-to-day operations issues. Participates in process improvement projects.

What will you do?

• Manufacture advanced products and complete batch records following cGMPs.
• Products include reagents, calibrators, buffers, controls, etc.
• Perform in-process assays using clinical analyzers. Review and analyze data.
• Weighing, transferring, and mixing of chemicals as required.
• Perform product filtrations.
• Maintain and analyze lot histories for trends and discrepancies
• Review and approve completed batch records.
• Train/Lead Scientist 1 and 2 on equipment/procedures/processes
• Write, review, and modify SOPs, work instructions and reports.
• Initiate and complete DCO and Change Control
• Write, review, and execute process validations as appropriate.
• Initiate, evaluate, and support investigations for NCARs, CAPAs, and VARs.
• Keep department lead or manager updated on all issues.
• Backup for Staff Scientist and addresses roadblocks for the team.
• Technical expert for all products and serve as a technical resource for team.
• Perform ERP transactions for work orders and inventory.
• Lead 6S and participate in Kaizen and other process improvement efforts
• Cross-trained in other streams
• Perform other job duties as required.

How will you get here?

Education:

BS/BA in life scientific discipline (biology/biochemistry) with 3-5 years of related experience and/or training preferred. AA degree with 4-6 years related experience may be substituted.

Experience:

• Experience in working with potentially hazardous chemicals and human source materials
• Laboratory skills and knowledge of safety precautions
• IVD manufacturing experience
• Experience with troubleshooting/investigations/NCARs/planned deviations is a plus

Knowledge, Skills, Abilities:

• Laboratory skills and knowledge of safety precautions
• Familiarity with Quality System Regulations and ISO 13485 regulations
• Must perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
• Strong laboratory skills including pipetting, safety, and hazardous chemical handling
• Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics
• Self-sufficient, self-motivated, and focused
• Demonstrated ability to lead
• Must be able to lift 25 lbs routinely and 50 lbs occasionally.