Senior Scientist, Analytical

Location
Foster City, CA, United States
Posted
Jan 01, 2021
Ref
1657305915
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Vaxcyte , Inc. (Nasdaq: PCVX) is a next - generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell - free p rotein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline include s pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad - spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX - 24, is a preclinical, 24 - valent broad - spectrum pneumococcal conjugate PCV with preclinical proof -of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX - XP, a PCV w ith an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX - A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX - PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds.

Summary:

Vaxcyte is looking for an energetic , self - motivated and talented individual to join our CMC team . The candidate must have proven record of analytical development and characterization, and hands on experience in using LCMS and various analytical techniques to characterize proteins and conjugates. The candidate will independently develop analytical methods (including but not limited to: different modes of chromatography, LCMS , CE, colorimetric and light - scattering technique) for characterization and quality control purpose. Additional responsibility will also include analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer betwee n our company and external CMO partner groups. Essential Functions:
• Independently propose, develop and transfer analytical methods for characterization and quality control of proteins , and pr otein -polysaccharide conjugates, to support process development/characterization and the establishment of appropriate manufacturing control strategies
• The job responsibility may also include identifying suitable CRO or research institute partners to co -develop analytical methods. Develop project plans and analytical technical roadmap with identified external partner. Provide appropriate oversight of project conducted externally by critically r eview ing analytical development data , providing necessary guidance and troubleshooting solutions to move project forward, review ing and approving analytical development reports and analytical method SOPs .
• Author protocols, reports, and regulatory submissions as appropriate
• Partner with process development scientists, CMC functional heads and project management to deliver the project milestones.

Requirements:

• PhD in Chemistry , Analytical Chemistry preferred, with 3 + years relevant industry experience ; MS or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required
• Extensive hands on experience in using LCMS and various analytical techniques to characterize proteins and their conjugates is a must.
• In depth knowledge on mass spectrometry in general and solid understanding of theory, operating principles and advantages/disadvantage of various mass spectrometers. Demonstrate capability to apply the most suitable MS technology to solve problems in hand.
• Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track r ecord of end to end delivery to meet the analytical challenges, from analytical technology selection and method develo pment to transfer and validation.
• E xtensive hands - on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates
• Experience working in a regulated (GLP / GMP) environment
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation , and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics
• Self - starter with ability to map out project milestones , apply sound judgment, excellent project management and problem solving skills to delivered desired outcomes within timelines
• Strong planning and tracking skills, well -organized, results oriented, capable of managing multiple projects with respect to priorities and resource.
• Adaptable fast learner with excellent skills for integrating and interpreting interdisciplinary connections
• Able to work in a fast-paced, cross-functional environment and collaborate effectively with other team members
• Extensive technical writing experience in drafting method protocols, SOPs and reports
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats
• Attention to detail and excellent skills in record keeping / documentation

Reports to: Senior Director, Analytical Development & Quality Control

Location: Foster City, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.