Scientist/Sr. Scientist

Summary:   
The Scientist/Senior Scientist candidate will assume an exciting leadership role primarily focused on supporting external Analytical Development activities to meet company pipeline objectives.  The candidate will manage CMO/CRO analytics activities to advance preclinical/clinical stage products through development, regulatory submission, and approval.  He/She will direct method development, transfer, and validation activities, as well as testing of GMP materials.  The candidate will assure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards.  Projects will include a broad range of methods for characterization and product testing requiring strong competencies in chemical and physical techniques applied to in-process materials, drug substance and drug product.  The candidate must be able to effectively communicate results and issues to peers, management and customers, internal and external (CRO/CMO), with excellent professional standards.  The candidate may also be called upon to support internal Analytical Development activities.

Responsibilities:
•             Management of CMO/CRO analytics
•             Large molecule characterization by various techniques, including biochemical/biophysical, chromatographic, spectroscopic/spectrometric methods.
•             Management of development, qualification, validation, and transfer of analytical test methods for testing in-process materials, drug substance, and drug product
•             Manage contract service providers engaged in method development, characterization, and testing activities
•             Author and review protocols, reports, test methods, and SOPs 
•             Conduct and document investigations following SOPs and company requirements
•             Maintain accurate and complete laboratory notebooks and records following GMP and good documentation practices
•             Generate analytical data and reports as well as CMC sections of INDs, NDAs and other regulatory filings

Qualification Requirements:
•             Bachelor’s/Master’s degree in molecular biology, chemistry, or similar discipline and 5 to 10 years of experience working with biologics/biopharmaceuticals, or Ph.D. and 5+ years’ experience
•             A minimum of 3 to 5 years in a supervisory role in a GMP biopharmaceutical environment including comprehensive knowledge of analytical requirements for biopharmaceutical development and commercialization
•             Experience in analytics of nucleic acid therapeutics, biopharmaceuticals, or large molecule characterization and testing from early through late-stage development
•             Strong leadership experience 
•             Good understanding of regulatory requirements, including ICH, USP/EP, FDA/EMA 
•             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
•             Regular international travel expected

Desired Technical Skills and Experience
•             Experience managing and working with contract service providers
•             Characterization and analysis of nucleic acids, proteins, antibodies, viruses, or virus-like particles
•             Characterization and quantitation of complex adjuvants and antigens (proteins, viruses, virus-like particles, nucleic acids)
•             Experience developing and validating analytical methods (e.g., HPLC, LC-MS, UV/Vis, fluorescence spectroscopy, PCR, nucleic acid sequencing, etc.)
•             Basic computer skills, including MS Word, Excel, PowerPoint etc.
•             Knowledgeable in the use and application of statistical software
•             Strong assessment and troubleshooting skills
•             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
  • Location: San Diego
  • Type: Permanent
  • Job ID: RH5250991129