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About you:

You are an experienced QC professional who has managed all Quality Control (QC) activities including incoming material testing, in-process testing, lot release testing, stability, and complaints, QA on-the-floor activities, line clearance, material control, equipment systems, and Contract Manufacturing QC oversight and method transfer activities. You are accustomed to driving resolution to test result issues. You enjoy working with cross-functional team members to ensure alignment with Quality Systems. You are a skilled supervisor who coaches and mentors your team.

About us:

Vivani Medical is an emerging biopharmaceutical company located in Emeryville, CA (soon to be in our new facility in Alameda). We develop very small, sub-dermal drug implants utilizing our proprietary NanoPortalTM technology platform which enables delivery of a broad range of medicines to treat chronic diseases of six months or longer. Our products, designed to address poor adherence, will significantly improve patients lives and provide assurance to the physicians who treat them. Come join us.

Significant Duties & Responsibilities

• Hands-on analytical testing of GXP material.
• Troubleshooting/maintaining analytical equipment.
• Review method development reports and feasibility and evaluate suitability of methods for validation.
• Support the validation implementation of QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
• Perform QC review/approval of analytical test data for drug substance/product batch release and stability test data.
• Coordinate stability activities, compile/analyze stability data/reports and perform data trending.
• Lead OOS/OOT investigations and other non-conforming investigations.
• Review/approve controlled GMP documents, e.g., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, etc.
• Review development reports for data integrity and regulatory compliance; review/author CMC content incorporated into regulatory submissions.
• Compile/archiving data packages, protocols, reports, methods etc.
• Support cGMP audits of contract laboratories and contract manufacturers.
• Serves as Quality Control Subject Matter Expert for audits.
• Support effective communication with CMOs and deliver QC objectives in accordance with project timelines.

Requirements

Education and Experience

• BS in Chemistry or equivalent
• Minimum 5 years in a pharmaceutical QC laboratory.
• Minimum 2 years in a supervisory role.
• Validations incorporating Part 11.
  

Skills and competencies

• HPLC expertise using Thermo Fisher (Dionex) or Agilent including reverse phase and normal phase.
• Analysis using standard testing equipment (Karl Fischer, pH meter, etc.)
• Statistical analysis using JMP or Minitab
• Expert in Excel preparing formulas and graphs.
• Author protocols/reports for Analytical equipment validation and method validations.

Must be legally authorized to work in the US.

Prefer

• MS in Chemistry or equivalent.
• ASQ Quality Auditor or Quality Engineer certification.
• Six Sigma Green Belt certification.
• Experience using Chromeleon software.

Physical Demands

• May be required for extended times to stand, walk, sit, reach with hands and arms, balance, or stoop.
• Requires fine motor skills and dexterity.
• Ability to lift up to 25 lbs.
• Meet visual acuity (vision) screening standard for a California drivers license (20/40 with both eyes tested together, and. 20/40 in one eye and at least, 20/70 in the other eye).

Working Conditions

• Working in close quarters with others
• Work in laboratory and hoods were fumes may be present
• Laboratory may contain toxic chemicals.
• PPE is required.
• Biohazard area which requires bloodborne pathogen training.
• This is an onsite position, with remote work from time to time.
• The position may require weekend work or travel.

Salary range DOE: $115K - $170K

Benefits

• Flexible scheduling
• Competitive Medical, Dental, and Vision , FSA and HSA
• Stock options
• Basic life insurance
• Long-term disability insurance
• 401(k): company safe harbor match up to 4%
• Home office stipend