Staff Engineer, Conjugation Development and Clinical Manufacturing
San Carlos, CA, USA
Posted on Tuesday, September 12, 2023
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
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 Staff Engineer with significant experience in Process Characterization (PC) and Process Validation (PV) Stage 1&2 to join the Conjugation process team. The candidate will participate in the design and execution of PC strategy for the Conjugation portion of the manufacturing process that will enable a timely and successful PPQ campaign. Given that VAX-24 contains 24 unique Conjugate Drug Substances, this validation strategy will require creative approaches and excellent judgment as to the most critical parameters to characterize. The candidate will also be responsible for CMO oversight.
- Assist in the development of a high-level plan for validating the Conjugation process – establishing the required outputs of the PC scope such that a PPQ campaign can be run successfully and on time.
- Work with Process Development SMEs within the group and at CMO to define the more granular details of the PC experiments.
- Develop creative, yet scientifically justified, solutions to characterize this process more efficiently across Vaxcyte’s suite of serotypes.
- Work with Engineering SMEs within the group and at CMO to design Commercial scale equipment that enables a well-controlled process, also work with these SMEs to ensure scale down model qualification is complete and rigorous.
- Work with CMO counterparts to define details of PPQ strategy, and make sure the PC scope is aligned with this strategy.
- Work with internal stakeholders (e.g. Regulatory) to ensure that the Conjugation validation strategy fits within the program-wide strategy.
- Contribute to the detailed timeline for the activities that must be completed prior to a PPQ campaign – communicate to team when activities are at risk of causing delays to timeline.
- Lead the authoring of PC reports, review PPQ protocols along with CMO counterparts.
- Participate in scale-up activities to support manufacture of Phase 3 and Commercial scale quantities of the VAX-24 Conjugate Drug Substances.
- Contribute to CMO Manufacturing oversight via document review, person in plant responsibilities, and troubleshooting when necessary.
- Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs.
- Present/communicate strategies and status updates to the Conjugation Development team as well as broader CMC team.
- Serve as a guide and mentor to junior team members.
- PhD in Chemical/Biochemical Engineering or similar, with 5+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.
- In depth experience with PC/PV for a Bioconjugate process, downstream Protein process, or small molecule chemistry process; expertise in TFF unit operation a significant plus.
- Broad experience in late-stage development.
- Both practical experience with and theoretical knowledge of engineering principles involved in scaling processes from development lab to pilot / manufacturing plant.
- Working knowledge of the requirements of GMP manufacturing, preferably with hands on GMP experience through either a Manufacturing or MSAT role.
- Experience working with CMOs highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities.
- Strong understanding of the principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically modelled experiments.
- Experience with late-stage process development activities such as risk assessments (eg, FMEA) and identification of CPPs and CQAs is a plus.
- Experience writing IND sections is a plus.
- Excellent judgment when assessing risk – strong understanding of when to expend resources to reduce risk and when the level of risk is acceptable to move forward.
- Strong ability to motivate, mentor, and connect with junior team members.
- Strong sense of organization, preferably with experience managing timelines using a tool such as Microsoft Project.
- Ability to work across several teams to pull required information from SMEs and integrate it into centralized plan.
- Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
- Strong interpersonal skills, with excellent written and verbal communication skills.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Director, Conjugation Development and Clinical Manufacturing
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $162,000 - $175,000
Send resumes to:
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.