- Product Investigations: The candidate will play a pivotal role in leading and conducting extensive investigations related to quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine drug product development, from early development to late-stage phases. These investigations will rely on the robust application of Design of Experiment (DoE) methodology and the utilization of a wide array of analytical techniques. A core requirement for the candidate is a deep understanding of the mechanisms of degradation and stability of biomolecules.
- Product Knowledge: The candidate will be responsible for strategically expanding our knowledge base, ensuring that our understanding of these complex drug products is not only deep but continually broadening. The candidate should be a creative problem solver, capable of identifying challenges and developing innovative solutions to overcome scientific hurdles in drug product development.
- Data Analysis: Analyse, interpret, and report on investigation findings, identifying root causes and proposing corrective and preventive actions.
- Documentation: Maintain thorough and accurate records of investigations, including reports, test results, and documentation of all activities performed.
- Regulatory Compliance: Ensure all investigations are conducted in accordance with regulatory requirements and company SOPs, contributing to the development and maintenance of compliance standards.
- Support formulation development activities, including stability studies for thermal, freeze/thaw, and agitation, kinetic analysis of antigen degradation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
- Process Improvement: Identify opportunities for process improvements and optimization in early and late-stage product investigation procedures.
- Communication: Effectively communicate investigation findings and progress to both internal teams and external stakeholders as necessary.
- Collaborate with external Contract Development Manufacturing Organizations (CDMOs) to facilitate the testing of drug products, providing essential support for investigative processes.
Requirements: - A Ph.D. or Master's degree in a relevant scientific field (e.g., pharmaceutical sciences, biophysics, biochemistry, or related discipline) is preferred.
- Preferable at least 3-5 years of experience in vaccine drug product development and product investigation, with a focus on adjuvanted vaccine drug products.
- Strong analytical skills, with proficiency in a range of analytical techniques such as MSD, ELISA, Laser diffraction, liquid chromatography and adjuvant antigen binding characterization.
- The candidate should have experience in the use of statistical analysis and Design of Experiments (DoE) for complex system optimization.
- 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 a distinct advantage.
- Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
- The candidate should have 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 (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team and well as across other teams.
- Detail oriented, rigorous and excellent skills in record keeping/documentation.
Reports to: Director, Formulation Development
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $169,000 – $185,000
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Staff Scientist, Formulation Development - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team.
The Staff Scientist - Drug Product Development will assume the critical role of overseeing and executing investigations while developing and deploying strategies aimed at resolving a range of product-related challenges, extending from the initial stages to the more advanced phases of drug product development. This role will primarily center on the domain of aluminum salt adjuvanted vaccine drug products. Collaborating closely with cross-functional teams, the Sr. Scientist will play an integral part in guaranteeing the quality, safety, and adherence to regulatory standards of our products. This position is for a scientific role which will be mostly lab based, which will require excellent scientific judgement, independence, rigor and thorough record keeping. In addition, this role will require significant expansion and deepening of our core and scientific understanding of the highly complex drug products under development, achieved through collaboration with external academic and commercial partners.
The primary responsibility for the incumbent will be to support formulation drug product development activities of Vaxcyte's lead product candidate from early-stage development through Phase 3 and culminating in BLA filing and commercial manufactures.
Essential Functions:
Staff Scientist, Formulation Development professionals in San Carlos
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Alex Hero
Instructional Designer