Sr. Engineer, Polysaccharide Pilot Plant

Job Details
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 a Senior Engineer with experience in downstream purification early-stage development and late-stage process characterization to join the Polysaccharide Downstream Pilot Plant team. The candidate will be responsible for planning, designing, executing, and analyzing experiments for a qualified scale down model polysaccharide production process.
In addition, this person exhibits strong leadership capabilities and can mentor junior engineers and associates and collaborate with cross-functional teams to support project goals and timelines. This position 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 will write detailed technical reports, present experimental results internally, and potentially interface with external CMO partners.
Essential Functions:

• Design, execute, and analyze experiments for the downstream polysaccharide pilot scale process in support of process characterization
• Support and lead early and late-stage process development for downstream polysaccharide process, including performing risk assessments, review of characterization studies and validation protocols.
• Execute experiments for polysaccharide purification including Akta chromatography skids, TFF system, depth filtration systems, and centrifugation.
• Operate and maintain instrumentation for polysaccharide purification including TFF systems, Akta chromatography skids, centrifuges, and depth filtration units.
• Perform analysis and interpret results for polysaccharide and impurity assays (Anthrone, Lowry, SEC-MALS, HPAEC-PAD etc.).
• Provide manufacturing support in reviewing manufacturing documents, troubleshooting problems, compiling and analyzing data.
• Provide technical guidance and collaboration for junior engineers
• Prepare and review technical reports, SOPs, batch records, and regulatory documents.
• Authoring/development of experimental protocols prior to experiment execution and respective results and reports.
• Present/communicate data to polysaccharide team as well as broader CMC team.
• Contribute to technical discussions within the CMC team.
• May have direct reports in the future. Works within a team environment and provides support as necessary to further the team's initiatives.

Requirements:

• PhD in Bioprocess Engineering, Chemical Engineering, Biotechnology or a related discipline, with 5+ years of industry experience or combination of industry and postdoctoral research; M.S. with 8+ years of industry experience; or B.S. with 10+ years of industry experience.
• Strong scientific background in traditional purification unit operations such as chromatography, tangential flow filtration, and centrifugation with hands on experience is a must.
• Demonstrated proficiency with engineering principles involved in scaling of processes between lab and manufacturing and development of a scale down model.
• Experience in late stage process characterization a plus.
• Understanding with Design of Experiments principles and ability to perform statistical data analysis
• Working experience of GMP requirements in a manufacturing setting.
• Proficient with computer programs such as Microsoft Excel, Word, Powerpoint, and JMP.
• Demonstrated success working in a cross-functional team environment on multiple projects; ability to work effectively as a member of a team to deliver results.
• Strong interpersonal skills, with excellent written and verbal communication skills.

Reports to: Associate Director, Polysaccharide Manufacturing
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $152,000 - $170,000