Senior Scientist / Engineer, Polysaccharide Process Development

Location
Foster City, CA, United States
Posted
Mar 01, 2021
Ref
68526421
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next - generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell - free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad - spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX - 24, is a preclinic al, 24 - valent broad - spectrum pneumococcal conjugate PCV with preclinical proof -of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX - XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX - A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX - PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds.

Summary:

Vaxcyte is looking for an energetic and talented Sr. Scientist/Engineer to contribute to the Polysaccharide development and manufacturing group within the CMC team. Vaxcyte is developing a multi - valent polysaccharide - based conjugate vaccine, based on a novel carrier protein produced using the Xpress CF platform. Polysaccharid es are a critical component in conjugate vaccines. The successful candidate will have practical laboratory experience developing processes related to biotechnology, biopharmaceuticals, or vaccine industries. The candidate will be eager to utilize and lea rn new laboratory skills as this person will be responsible for collaboration on experimental design and execution of experiments to further the polysaccharide development and manufacturing program. This position will require >50 % time in the lab initially and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate will interface closely with the CMC team, write detailed technical reports, present experimental results int ernally, and interface with external CMO partners. Essential Functions:
• Design and execute experiments to further develop downstream processes including:
- Continuous centrifugation and depth filtration development
- TFF optimization and characterization
- Chromatography screening, optimization and characterization
- Microfluidization development
- Scal ing studies
- Development of a scale -down model
• Operate and maintain instrumentation for polysaccharide purification including automated TFF systems, Akta chromatography skids, automated filtration units and continuous centrifuges
• Perform analysis and interpret results for polysaccharide and impurity assays (Anthrone, Lowry, SEC- MALS , HPAEC - PAD etc... )
• Assists in d esign and execu tion of downstream process characterization studies
• Develop purification strategies for pipeline projects
• Keep accurate and current records of development experiments and/or project related activities in laboratory notebooks or electronic notebook
• Prepare technical reports, summari es of testing, and detailed protocols
• Review executed protocols and batch records
• Present/communicate data to polysaccharide team as well as broader CMC team
• Contribute to technical discussions within the CMC team
• Research literature to identify novel methodologies and solve scientific problems which apply to the overall program
• Tech transfer purification processes to external manufacturing groups
• Writes, reviews, and approves R&D protocols, batch records, and reports in support of process development, and assay development
• Works within a team environment and provides support as necessary to further the team's initiatives

Requirements:

• PhD in Bio process 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 1 0 + years of industry experience
• Practical experience with and theoretical knowledge of traditional processing unit operations including TFF , depth filtration , continuous centrifugation and chromatography
- Hands- on experience with automated process equipment such as Akta instruments, KR2i or P endotech TFF systems, microfluidics microfluidi zers and continuous centrifuges
• Solid understanding of the principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically -modelled experiments
- Process characterization experience is a plus
• Demonstrated proficiency with engineering principles involved in scaling processes from lab to pilot scale as well as developing a scale -down model
- Prior experience in polysaccharide development is a plus
• Proficient with computer programs such as Microsoft Excel, Word, Powerpoint, Visio and JMP
- Experience with process modelling software a plus
• Working knowledge of the requirements of GMPs
• E xperience working with C D MOs and ability to effectively communicate experimental design and results to a CD MO
• Ability to travel internationally to a CMO as some international travel may be required
• Demonstrated success working in a cross -f unctional team environment on multiple projects ; a bility 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 Development and Manufacturing

Location: Foster City, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.