Company Profile: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 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-XP, a PCV with an expanded breadth of coverage of greater than 30 strains; 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. 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 100 employees and anticipates continued, significant growth. On January 6, 2022, Vaxcyte announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for VAX-24, its lead vaccine candidate. The Company expects to initiate the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and announce Phase 2 topline immunogenicity, safety and tolerability results by the end of the year. VAX-24 was designed to prevent 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-XP, 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.Summary:
Vaxcyte is seeking a highly energetic, talented, pro-active, and self-motivated individual to join our growing Facilities and Lab Operations Team. The Metrology Engineer is a very hands-on role and will be responsible for the maintenance, IQOQ, calibration, set up, configuration and ensuring critical lab equipment is operational and ready for use. The Metrology Engineer is a subject matter expert and a critical point of contact for lab personnel, fielding service requests, triaging and assigning tasks, and helping to maintain a culture of safety and compliance.
This role will be instrumental in ensuring our Facilities and Lab Operations department and laboratories are ready for growth with Vaxcyte’s current and projected product pipelines. This department enables the labs to run efficiently and allow the scientists to focus on delivering their respective pipelines. This role will own this department’s transformational journey In centralizing critical lab equipment maintenance, operation and calibration. A successful candidate will have a demonstrated track record in using Standards of Primary Instrument Standards applied in pharmaceutical industry. Additionally they will possess the ability to interact with various departments/teams across Vaxcyte. Specific experience in areas such as Gas/Liquid Flor, Temperature, Electrical, Pressure, Optics, Mass/Weigh and Light Measurements is highly desired. Salary and compensation will be commensurate with the experience of the successful candidate. This is a full-time, on-site role that reports to the Sr. Director of Facilities.Note: rotational, shared 24x7 support is required of this role.
- Own the metrology program.
- Drive improvements in service level, efficiency and cost reduction through standardization of common practices. Create a platform to share ideas within the lab operations team and with clients including the application of best practices. Establish relationships and service standards and coverage to meet lab-based personnel’s needs.
- Build and improve relationships with partners (i.e., Research Associates, Scientists) and key functions within Vaxcyte (i.e., Project Management, Procurement, Legal, Accounts Payable) through proactive engagement and communication.
- Develop and realize a service model with clear roles and responsibilities and decision making.
- In Collaboration with lab leadership, proactively identify and resolve risks/issues related to lab equipment operation and availability.
- Responsible for developing and executing a strategy for equipment and instrumentation maintenance and operation.
- Establish relationships and service standards and coverage to meet lab-based personnel’s needs.
- Partner with key stakeholders to develop and continuously strive for a proactive, high bar safety culture.
- Prepare calibration procedures/job plans and associated training materials.
- Applies engineering experience to ensure that instrumentation and controls systems used in assigned facilities are accurately specified, installed, programmed, and calibrated to perform design function.
- Performs periodic assessment of field device calibration frequencies, and addressing out of tolerance (OOT), accessing instrument performance for replacement / upgrade.
- Upkeep calibration procedures including training and qualifying calibration technicians.
- Provide leadership for 24/7 field support to solve, identify, and resolve metrology issues.
- Own the equipment’s and/or systems related to metrology standards.
- Provide mentor and technical expertise to the technicians to support the infrastructure operations.
- Understanding of GMP regulations and Good Document Practices.
- Performs calibration of Vaxcyte primary and working standards following prescribed Vaxcyte procedures.
- Draft and develop needed procedures.
- Understands basic measurement uncertainty principals.
- Records calibration data gathered during calibration within CMMS (Computerized Maintenance Management System).
- Identifies appropriate standards and uses applicable measurement procedures.
- Generates certificates of calibration and/or out of tolerance reports as required.
- Maintains secondary or intrinsic and/or working calibration standards.
- Assists in maintaining laboratory in state of compliance to ensure audit reediness.
- Must understand measurement assurance program concepts.
- Performs other duties as assigned.
- Understanding of measurement traceability.
- Working with Calibration Software.
- Bachelor’s degree in science or engineering related discipline, plus 10 years of progressive experience or
- Master’s degree in science or engineering related discipline plus 5 years of experience.
- Experience in HPLC/FPLC, PH meters, balances, plate readers maintenance and operations.
- o Experience in SEC-MALS and or Mass Spectrometer operations and maintenance is a plus.
- Proven track record in managing and scaling lab operations.
- Experience working in an R&D and GMP and GLP laboratory environment is a plus.
- Highly customer service oriented and has a track record of anticipating the needs of all customers, including bench scientists.
- Demonstrated drive, curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment.
- Meticulous with details.
- Ability to constructively challenge, improve and develop lab operations practices and processes.
- Self-motivated with the proven ability to take ownership and deliver results in an environment with ambiguity and change.
- Ability to collaborate cross functionally and align stakeholders to a common problem or solution.
- Superior communication and interpersonal skills – Oral, written and formal presentation skills.
- Demonstrated ability to develop new lab operations practices (from a blank sheet of paper) and standard operating procedures.
- Creative and proactive problem solver; keen ability to anticipate needs in a lab environment, solving problems with sound judgment.
- Experience managing and prioritizing inputs from diverse stakeholders to deploy a plan that meets the needs of the business.
- All Vaxcyte employees require vaccination against COVID-19.
Senior Director of Facilities Location:
San Carlos, CA Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.