Associate Scientist II (Contract), Drug Product Analytics

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 products, external analytical, and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods.

Requirements

• BS degree in Chemistry, Biochemistry, or related field with minimum 2 years of industry experience, or MS degree with minimum 1 years of industry experience.
• Established practical experience in the analytical characterization of large biomolecular Drug Products in pre-filled syringes and vials.
• Experience executing bioanalytical components of stability studies and release tests.
• Experience in plate-based assays, immunoassay/ELISA, chromatography methods, spectrometric, and biophysical methodologies is preferred.
• Experience in authoring analytical technical documents, including method protocols, SOPs, and reports, as well as experience recording and templating electronic laboratory notebooks (eLN).
• High degrees of both flexibility and organizational skills as well as an eagerness and ability to learn, to effectively navigate Vaxcyte’s multiple projects and timelines.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team, as well as train other analysts and team members.
• Detail-oriented, rigorous, and excellent skills in record keeping.

Qualifications

• BS degree in Chemistry, Biochemistry, or related field with minimum 2 years of industry experience, or MS degree with minimum 1 years of industry experience.
• Established practical experience in the analytical characterization of large biomolecular Drug Products in pre-filled syringes and vials.
• Experience executing bioanalytical components of stability studies and release tests.
• Experience in plate-based assays, immunoassay/ELISA, chromatography methods, spectrometric, and biophysical methodologies is preferred.
• Experience in authoring analytical technical documents, including method protocols, SOPs, and reports, as well as experience recording and templating electronic laboratory notebooks (eLN).
• High degrees of both flexibility and organizational skills as well as an eagerness and ability to learn, to effectively navigate Vaxcyte’s multiple projects and timelines.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team, as well as train other analysts and team members.
• Detail-oriented, rigorous, and excellent skills in record keeping.

Skills

• Excellent scientific judgement.
• Independence.
• Rigor.
• Thorough record-keeping.

Benefits

• Equal Opportunity Employer.

Pay

• Hr: $51/hr.
• Hr: $56/hr.

Schedule

• Onsite (minimum of 4 days per week).