Address
Form of work
SalaryJoin our Mission to Protect Humankind!
Vaxcyte 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:
We look forward to welcoming a Bioprocess Engineer with a solid understanding of bio-chemical engineering fundamentals and modeling expertise to support our laboratory, pilot and clinical scale process development, technology transfer to internal and external GMP production facilities for our novel cell free expression-based therapies. Our team’s goal is to develop and implement robust commercial manufacturing processes. This Process Engineer role requires close working relationships with Manufacturing, Analytical Development, Supply Chain, Quality, Regulatory and CMC Program Management functions as well as with external CMO teams.
We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations (e.g. bioreactors, chromatography, UF/DF, normal flow filtration, mixing and novel harvesting systems). The ideal candidate should have a strong engineering background and understanding of these unit operations and will focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust commercial manufacturing. These skills should be complemented with a track record of excellent written and oral communication skills required to operate within a Quality Management System. A history of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modelling techniques are strong pluses.
Success in this role would be demonstrated by effective participation in process design/development, optimization, investigations, and performance of experiments to identify/confirm associated root causes, followed by characterization and implementation of effective process changes to increase success in commercial production. This position bears the potential for significant growth in a dynamic organization.
Essential Functions:
- Engineer new and modify existing processes to ensure right first-time process start-up and successful new product launches.
- Leverage mass transfer, mixing principles and modelling towards effective scale-up of the process and transfer to GMP sites.
- Represents MSAT on project teams as technical subject matter expert (SME) and interface with Pilot Plant, Manufacturing, Supply Chain, Facilities Engineering and Quality functions as well as external partners.
- Develop process understanding and expertise.
- Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc.).
- Authors, reviews change controls including managing change implementation.
- Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ new product launches. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure.
- Monitors and reports on process performance data analysis.
- Ability to share 24/7 on call support activities during production.
- Apply Operational Excellence principles to lead continuous improvement for process improvements.
Requirements:
- Masters degree in Engineering with 1-3+ years of relevant pharmaceutical/biotech experience, Bachelors degree with 5+ years of relevant industry experience.
- Proven ability to multi-task, record of accomplishment and self-directed leadership in academia and/or industry setting is required.
- Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
- Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.
- Good interpersonal, team, and collaborative skills are required.
- Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
- Familiarity with Excel, Word, and PowerPoint and basic statistical techniques are required, experience in Statistical Design of Experiments, Python, CFD modelling is preferred.
Reports to: Director, Protein Development and Clinical Manufacturing
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $124,000 – $133,000
Send resumes to:
careers@vaxcyte.com
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
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.
