Analytical Chemist I-IV

About the Company

Vivani Medical is an emerging biopharmaceutical company located in Alameda, CA. We develop miniature, sub-dermal drug implants utilizing our proprietary NanoPortalTM technology platform which enables delivery of a broad range of medicines to treat chronic diseases for six months or longer. Our products, designed to address poor medication adherence and improve tolerability, aim to significantly improve patient's lives and provide assurance to the physicians who treat them. Come join us!

About the role

This position is responsible for performing analytical testing in support of research and development activities. The chemist will be involved in method development, raw material testing, formulation, drug product, stability, and support complaint investigations. The Chemist is also responsible for laboratory material control, laboratory equipment qualifications and supporting method validations, and Contract Manufacturing testing. This individual works closely with cross-functional team members to ensure alignment with department and company goals. This position works closely with other Chemists, Quality Control, Research, and other departments. This position reports to the Senior Director of Quality.

Significant Duties & Responsibilities

• Hands-on analytical testing of GXP material.
• Performing method development
• Troubleshooting/maintaining analytical equipment.
• Support the validation implementation of methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
• Perform peer review/approval of laboratory notebooks and reports.
• Perform stability activities, assist in compiling/analyzing stability data/reports, and perform data trending.
• 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 testing by contract laboratories and contract manufacturers.
• Maintain and calibrate laboratory equipment.
• Support effective communication and deliver department objectives in accordance with project timelines.
• This list is not comprehensive and other tasks and duties may be added as needed.
• This is an onsite position, with remote work from time to time

Requirements

Education

• BS in Chemistry or equivalent. MS preferred.

Experience

• Minimum 2 years in a pharmaceutical chemistry laboratory
• Experience using Chromeleon software is preferred.
• 2 years method development

Certifications or Licenses

• Six Sigma Green or Black Belt preferred.

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.)
• ELISA experience a plus
• Statistical analysis using JMP or Minitab
• Expert in Excel, preparing formulas and graphs.
• Author protocols/reports

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.
• Requires high visual acuity (prescription lenses are acceptable)

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
• Safety training required
• This role may require weekend work or travel, if applicable

Must be legally authorized to work in the United States.

Salary range: $68K - $164K DOE

Benefits

• Medical
• Dental and Vision
• Flexible Spending Account (FSA)
• 401K with Company Safe Harbor Match: 100% /up to 4%
• Life Insurance
• Long Term Disability
• Home Office Stipend
• Commuter benefits for those using public transportation
• PLUS weekly catered lunches and a well-stocked breakroom