- Assist the development, qualification, and transfer of analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, and vaccine targets
- Develop analytical methods and conduct characterization studies to support formulation development and the establishment of appropriate manufacturing control strategies
- Perform analytical method transfer to CROs/CMOs
- Perform appropriate CRO/CMO oversight by reviewing analytical method development data, reviewing and approving analytical method validation protocols and subsequent reports, and reviewing and approving analytical method SOPs
- Assist in the writing of protocols, SOPs and reports, and regulatory submissions as appropriate
- PhD in Chemistry, Analytical Chemistry preferred, Organic / Biochemistry considered, with 3+ years relevant industry experience; MS or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required
- Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track record of method development trouble shooting and validation.
- Extensive hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates
- Extensive hands on experience in using GCMS and various analytical techniques to characterize carbohydrates and related molecules is a plus.
- Direct experience operating Agilent HPLC using OpenLab/Chemstation software and/or Waters UPLC and Empower software for data acquisition and analysis
- 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 for small molecules, biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy
- Attention to detail and excellent skills in record keeping / documentation
- Extensive technical writing experience in drafting method protocols, SOPs and reports
- Project management skills including the ability to manage one's project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats
- Self-starter; ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members
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Scientist II, Analytical Development - San Mateo, United States - Vaxcyte Inc
Description
Job Description
Job DescriptionCompany Profile: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 protein 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 includes 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 with 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 and talented individual to join our analytical development team. The candidate will independently develop analytical methods (including but not limited to: different modes of chromatography and spectrometry such as MS, CE, colorimetric and light-scattering technique) and perform sample testing to support development and formulation of protein and conjugate vaccine targets. The successful candidate will also provide scientific mentorship and technical guidance for junior colleagues in analytical method development. Additional responsibility will also include analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer between our company and external partner groups.
Essential Functions:
Requirements:
Scientist II, Analytical Development professionals in San Mateo
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Santanu Biswas
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