Lead Scientist, Vaccine Formulation
2 weeks ago
Join Our Mission to Safeguard Humanity
Vaxcyte is a pioneering clinical-stage vaccine innovation firm dedicated to engineering high-fidelity vaccines that protect humanity from the dire consequences of bacterial diseases, which can lead to significant health challenges if not addressed.
Our efforts to combat and manage bacterial infections, including invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella, are just the beginning of our journey.
Our Approach: The way we work is as crucial as the work itself. Our collaborative efforts are guided by four fundamental core values:
- AIM HIGH: We strive for ambitious goals to create the most complex biologics aimed at safeguarding humanity.
- LEAD WITH HEART: Our leadership is characterized by a kindness-first, inclusive approach that fosters collaboration and constructive debate to achieve our business objectives.
- RETHINK CONVENTION: We embrace creative and intellectual diversity in all aspects of our work to innovate and continuously improve vaccine delivery methods.
- MODEL EXCELLENCE: The scale of our challenges demands a shared commitment to integrity, accountability, equality, and clarity in our communications and decision-making processes.
Position Overview:
Vaxcyte is seeking a dynamic and skilled individual to join our Formulation and Drug Product Development team. The Lead Scientist in Vaccine Formulation will play a vital role in overseeing and executing investigations while developing and implementing strategies to address a variety of product-related challenges, from initial development stages to advanced phases of drug product development.
This role will focus primarily on aluminium salt adjuvanted vaccine drug products. The Lead Scientist will collaborate closely with cross-functional teams to ensure the quality, safety, and regulatory compliance of our products.
Key Responsibilities:
- Product Investigations: Lead and conduct investigations related to quality issues, deviations, out-of-specification results, and anomalies throughout all stages of vaccine drug product development.
- Process Improvement: Identify and implement opportunities for process enhancements and optimizations in product investigation procedures.
- Data Analysis: Analyze, interpret, and report investigation findings, identifying root causes and proposing corrective and preventive actions.
- Documentation: Maintain comprehensive and accurate records of investigations, including reports, test results, and documentation of all activities performed.
- Regulatory Compliance: Ensure all investigations comply with regulatory requirements and company SOPs, contributing to the development and maintenance of compliance standards.
- Communication: Effectively communicate investigation findings and progress to internal teams and external stakeholders as necessary.
Qualifications:
PhD in Pharmaceutical Sciences, Chemistry, Biophysics, or Biochemistry with over 2 years of relevant experience preferred, or a BSc or MSc in pharmaceutical sciences, biophysics, or biochemistry with more than 7 (BSc) or 4 (MSc) years of industry experience.
At least 1-3 years of experience in vaccine drug product development and product investigation, particularly with adjuvanted vaccine drug products, is required. Strong analytical skills and proficiency in various analytical techniques such as Laser diffraction, liquid chromatography, MSD, ELISA, and adjuvant antigen binding characterization are essential.
Experience with biophysical and calorimetric methodologies applied to proteins and protein polysaccharide conjugates, such as Circular Dichroism, Fourier Transformed Infrared (FTIR) Spectroscopy, Fluorescence Spectroscopy, Differential Scanning Calorimetry (DSC), and Isothermal titration calorimetry (ITC) would be advantageous.
Outstanding collaboration skills and the ability to work across disciplines are crucial. The ideal candidate will possess scientific creativity and curiosity, with the capability to apply new technologies to complex drug product challenges. A proven track record of formulation development leadership for vaccines or biologics, along with excellent technical writing skills and experience in authoring development reports, SOPs, and regulatory filings, is required.
Strong written and verbal communication skills are necessary, with efficiency in communicating within interdisciplinary and cross-functional teams.
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