Join 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: 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. 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. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary: The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for an Associate Scientist II with experience in microbial fermentation and upstream processing to join the MFG/Process Development Team. The candidate will be responsible for collaboration on experimental design and execution of experiments to further develop and optimize upstream processes for polysaccharide manufacturing. The successful candidate will have practical laboratory experience related to upstream processes and eager to utilize and learn new laboratory skills. The role will require >50% time in the lab and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate may interface closely with the cross-functional team, write detailed technical reports, present experimental results internally, and may potentially interface with external CMO partners.
Essential Functions:
- Contribute to MFG process validation readiness, including technical review and implementation monitoring of validation/verification protocols and control strategies.
- Author and provide technical input for risk assessments supporting MFG activities and investigations.
- Assist in cross-functional collaboration in building out data infrastructure for MFG data compilation and trending.
- Review manufacturing documents and transfer in-process data to data repositories.
- Compile and analyze MFG data to support performance monitoring and provide key insights for supporting process development activities and/or MFG troubleshooting.
- Operate and maintain instrumentation for primary recovery operations, including but not limited to TFF systems.
- Record data in electronic laboratory notebooks and aid in writing technical summary reports.
- Perform analytical assays for process development and in-process manufacturing samples and maintain manufacturing and process development data repositories.
- Present data to the team to provide updates on MFG and small-scale development activities and contribute to technical discussions
Requirements:
- S./M.S. in biochemistry, bioengineering, chemical engineering or other related disciplines with 2+ years of experience.
- Prior experience with tech transfer, scale-up/scale-down, and familiarity with MFG GXP requirements.
- Prior experience with TFF, and other primary recovery operations.
- Experience with analytical methods such as plate-based assays, UV-spectrophotometry, and metabolite analyzers.
- Experience writing technical documents including lab operation protocols and data summary reports.
- Proficiency in computer programs including Microsoft Excel, Word, and Powerpoint.
- Experience with statistical software such as JMP, R studio, python, etc. for data analysis.
- Experience working with a CDMO is a plus.
- Familiarity with statistical methods for process characterization and validation is a plus.
- Familiarity with DOE principles and experience with DoE software (JMP) is a plus.
Reports to: Senior Engineer, Polysaccharide Process Development
Location: San Carlos, CA
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $105,000 - $114,500 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation: This role is not eligible for relocation assistance.
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.