Scientist/Senior Scientist, Analytical Development

Location
San Diego
Posted
Feb 15, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Scientist/Senior Scientist position will assume an exciting leadership role focused on supporting Analytical Development to meet company pipeline objectives.  The candidate will actively identify, design, carry out, and evaluate analytical activities to advance preclinical/clinical stage novel vaccines through development, regulatory submission and approval, as well as supervise a team of scientists engaged in method development, method validation, and testing activities.  The candidate will assure timely, appropriate method development, validation and implementation to meet project target profiles and ICH, USP, FDA, and EMA standards through a combination of internal and contracted activities.  Vaccine projects will include a broad range of methods for characterization and quality control requiring strong competencies in immunological and/or chemical techniques, both compendia and novel, applied to in-process materials, drug substance, and drug product.  The candidate must be able to effectively communicate results and issues to management and customers, internal and external, with excellent professional standards.

 Responsibilities:

  • Develop, qualify, validate, and transfer analytical test methods for testing in process materials, drug substance, and drug product
  • Perform GMP release and stability testing of pipeline products
  • Supervise internal scientists engaged in developing analytical and validating methods and performing release and stability testing of pipeline products
  • Interact with contract service providers to facilitate analytical development/validation and testing activities
  • Author and review development reports and method validation protocols and reports
  • Author and review test methods and SOPs
  • Follow SOPs and laboratory guidelines for daily laboratory operations and functions, and develop continuous improvements
  • Conduct and document analytical investigations following SOPs and company requirements
  • Maintain accurate and complete laboratory notebooks and records following GMP and good documentation practices
  • Author and review analytical data summaries to support batch release and stability assessments for clinical materials
  • Generate analytical data and reports needed for the CMC sections of INDs, NDAs and other regulatory filings
  • Perform maintenance and calibration of laboratory instruments and equipment
  • Maintain training record per GMP requirements

Required Qualifications:

  • Bachelor’s/Master’s degree in biology, chemistry, or similar discipline and 5+ years of experience working with biologics/biopharmaceuticals, or Ph.D. and 3+ years of experience
  • Ability to prioritize assignments and complete work in a timely manner with deadlines, fluctuating workloads, or last minute changes
  • Demonstrated ability to think and act independently and in a team, accept supervision, work quickly and accurately in a fast-paced environment, critically analyze data, and proactively solve problems
  • Strong project and/or people leadership experience
  • Experience in analytics of biologic drug characterization and testing from early through late development stages
  • Good understanding of regulatory requirements, including ICH, USP/EP, FDA/EMA as related to biologics
  • Ability to work independently and manage projects in a timely manner
  • Strong interpersonal skills with an eagerness to support colleagues in Analytical Development and internal CMC and Quality teams
  • Excellent verbal and written communication skills with a strong ability to work effectively with many internal and external customers

Technical Skills and Experience:

  • Experience in the analysis and characterization of proteins, antibodies, viruses, or virus like particles
  • Experience developing and validating physicochemical tests for complex biologics (e.g., SEC, IEX, RP-HPLC, CE, light scattering)
  • Experience with Waters Empower software is required; proficiency in this area is preferred
  • Proven experience troubleshooting equipment and/or method problems
  • Familiarity with standard laboratory techniques, including pH determination, spectroscopic methods, etc.
  • Solid general computer skills, including MS Word, Excel, PowerPoint, etc.
  • Knowledgeable in the use and application of statistical software is a plus
  • Experience Interacting with contract service providers is a plus