Scientist/Senior Scientist, Analytical Development - San Diego, CA | Biospace
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Scientist/Senior Scientist, Analytical Development

PaxVax, Inc.

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Location:
San Diego, CA
Posted Date:
6/27/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Antibody, Biology, Chemistry, Protein, Regulatory, Virology,

Job Description

The Scientist/Senior Scientist candidate will assume an exciting leadership role focused on supporting Analytical Development to meet company pipeline objectives.  The candidate will actively identify, design, execute, and evaluate analytical activities to advance preclinical/clinical stage novel vaccines through development, regulatory submission and approval.  He/She will supervise a team of scientists engaged in product characterization, method development, and method validation activities.  The candidate will assure timely and appropriate product characterization and method development activities 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 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.  

Responsibilities:
•   Large molecule characterization by various techniques, including biochemical/biophysical, chromatographic, spectroscopic/spectrometric methods.
•   Develop, qualify, validate, and transfer analytical test methods for testing in process materials, drug substance, and drug product
•   Supervise internal scientists engaged in analytical activities, including method development/validation, product/molecule characterization, and testing pipeline products
•   Interact with contract service providers to facilitate 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 needed for the CMC sections of INDs, NDAs and other regulatory filings
•   Perform and/or manage maintenance and calibration of laboratory instruments and equipment

Requirements

•   Bachelor’s/Master’s degree in biology, chemistry, or similar discipline and 5 to 10 years of experience working with biologics/biopharmaceuticals, or Ph.D. and 5+ years experience
•   Strong leadership experience
•   A minimum of 3 to 5 years in a supervisory role in a GMP biopharmaceutical environment
•   Experience in analytics of biologics or large molecule characterization and testing from early through late stage development
•   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
•   Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity

Desired Technical Skills and Experience:
•   Characterization and analysis of proteins, antibodies, viruses, or virus-like particles
•   Characterization and quantitation of complex adjuvants and antigens (proteins, viruses, virus-like particles)
•   Familiarity with glycans/polysaccharides and carbohydrate analysis
•   Experience developing and validating analytical methods (e.g., HPLC, LC-MS, DLS, UV/Vis, and fluorescence spectroscopy, etc.)
•   Familiarity with standard laboratory techniques (e.g., Karl Fisher, pH determination, spectroscopic methods, 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
•   Experience working with contract service providers