Vaxcyte
Associate Scientist II (contract), Drug Product Analytics
Vaxcyte, San Carlos, California, United States, 94071
Overview
Associate Scientist II (contract), Drug Product Analytics at Vaxcyte. This role is a contract position within the Drug Product Analytics team. Summary
Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate should have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, including immunoassays, chromatography, spectrophotometric techniques, light scattering, and particle sizing. Experience in analyzing vaccine and adjuvant-containing formulations is a plus. The role requires working on multiple projects with fluid prioritization to meet aggressive timelines. This is a lab-based scientific role requiring scientific judgment, independence, rigor, and thorough record-keeping. Essential Functions
Routine and non-routine analysis of internal release, development, and stability samples and reporting of data using multiple analytical techniques across the Drug Product working groups. Executing non-GxP stability study analysis for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance and adjuvanted vaccine Drug Product materials. Support the Vaxcyte PCV (and other projects), external analytical, and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods. Be flexible to work on multiple projects at once with prioritization to meet aggressive timelines; this role is predominantly lab-based with emphasis on rigor and record-keeping. Requirements
MSc with 1 year of experience, or a BSc with a minimum of 2 years of experience in the pharmaceuticals and/or biotechnology industries. Chemistry, Biophysics or Biochemistry preferred. Established practical experience in analytical characterization of large biomolecular Drug Products in pre-filled syringes and vials. Experience executing bioanalytical components of product release testing and long-term stability studies, including biochemical, biophysical, and compendial methods. Experience in plate-based assays (high-throughput screening, ELISA, etc), multiplexed immunoassay (MSD, Luminex, etc.), compendial methods (osmolality, pH, etc), and spectrometric methodologies. Experience in authoring analytical technical documents, including method protocols, SOPs, and reports, and recording/templates in electronic lab notebooks (eLN). Ability to navigate multiple projects and timelines with flexibility and organizational skills. Strong interpersonal and written/verbal communication skills to collaborate with the Formulation and Drug Product Development team and train other analysts. Detail-oriented with rigorous record-keeping. Reports to: Senior Manager, Drug Product Analytics Location: San Carlos, CA Expected Contract Length: 12 months Hourly Range: $48.00 - $54.00 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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Associate Scientist II (contract), Drug Product Analytics at Vaxcyte. This role is a contract position within the Drug Product Analytics team. Summary
Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate should have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, including immunoassays, chromatography, spectrophotometric techniques, light scattering, and particle sizing. Experience in analyzing vaccine and adjuvant-containing formulations is a plus. The role requires working on multiple projects with fluid prioritization to meet aggressive timelines. This is a lab-based scientific role requiring scientific judgment, independence, rigor, and thorough record-keeping. Essential Functions
Routine and non-routine analysis of internal release, development, and stability samples and reporting of data using multiple analytical techniques across the Drug Product working groups. Executing non-GxP stability study analysis for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance and adjuvanted vaccine Drug Product materials. Support the Vaxcyte PCV (and other projects), external analytical, and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods. Be flexible to work on multiple projects at once with prioritization to meet aggressive timelines; this role is predominantly lab-based with emphasis on rigor and record-keeping. Requirements
MSc with 1 year of experience, or a BSc with a minimum of 2 years of experience in the pharmaceuticals and/or biotechnology industries. Chemistry, Biophysics or Biochemistry preferred. Established practical experience in analytical characterization of large biomolecular Drug Products in pre-filled syringes and vials. Experience executing bioanalytical components of product release testing and long-term stability studies, including biochemical, biophysical, and compendial methods. Experience in plate-based assays (high-throughput screening, ELISA, etc), multiplexed immunoassay (MSD, Luminex, etc.), compendial methods (osmolality, pH, etc), and spectrometric methodologies. Experience in authoring analytical technical documents, including method protocols, SOPs, and reports, and recording/templates in electronic lab notebooks (eLN). Ability to navigate multiple projects and timelines with flexibility and organizational skills. Strong interpersonal and written/verbal communication skills to collaborate with the Formulation and Drug Product Development team and train other analysts. Detail-oriented with rigorous record-keeping. Reports to: Senior Manager, Drug Product Analytics Location: San Carlos, CA Expected Contract Length: 12 months Hourly Range: $48.00 - $54.00 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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