Associate Director, Lab Operations

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 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 initiated the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and expects to 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.
 
Summary:

Vaxcyte is seeking a highly energetic, talented, pro-active, and self-motivated individual to join our growing Facilities and Lab Operations Team. The Associate Director of Lab Operations is a very hands-on role and is responsible for the overall daily operations in Vaxcyte laboratories including vendor management, lab supply inventory, equipment maintenance requirements, and new equipment orders. The Associate Director of Lab Operations is a critical point of contact for lab personnel, fielding service requests, triaging and assigning tasks, providing training, and helping to maintain a culture of safety and compliance. They will oversee lab organization, lab storage, space allocation and waste management. They will work with appropriate departments on the development of necessary SOPs for safety compliance, training, equipment maintenance, calibration, and repair. They will work closely with procurement and the lab teams on CAPEX / OPEX budgeting and ordering of lab assets and service contracts. They will support lab asset inductions into CMMS, installations in lab spaces, and oversight of any qualification / validation verification activities. They will provide feedback on lab efficiency, operations, and policies as well as recommendations on any necessary changes or improvement.

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 the scientists to focus on delivering their respective pipelines. This role will own this department’s transformational journey including centralizing lab operations, standardizing common services, consolidating supplies, implementation of GMP and contracts and application of lean lab techniques (e.g., 5S, Kanban, visual management).  A successful candidate is well organized, flexible, creative and enjoys the challenges of managing a diverse and energetic office space. This is a full-time, on-site role that reports to the Director of Facilities.

Note: rotational, shared 24x7 support is required of this role.
Essential Functions:

• Establish and maintain an infrastructure to enable a structured laboratory operation. framework across Vaxcyte’s labs including capital plan/expenditures (from forecast to installation), lab equipment and instrumentation (i.e., contracts, maintenance, repair, calibration, upgrade and retiring), and lab consumables (i.e., contracts, procurement, order management, inventory management).
• Provide strategic direction, technical supervision, and support to the lab operations team who supports day-to-day operations. Lead operational performance reviews and establish business / individual objectives.
• Drive improvements in service level, efficiency and cost reduction through standardization of common practices, implementation lean lab techniques and utilization of metrics. 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.
• Establish and own a laboratory business continuity plan as well as extended-hours coverage and response plan.
• 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.
• Accountable for overall delivery and performance across lab operations.
• In Collaboration with lab leadership, proactively identify and resolve risks/issues.
• Responsible for developing and executing a strategy for servicing laboratories, including equipment and instrumentation, scheduling, and lab capacity utilization.
• Establish relationships and service standards and coverage to meet lab-based personnel’s needs.
• Support the development, budgeting, and execution of a three (3) year capital project plan.
• Establish common practices to obtain quotes, submit contract for legal review, place orders, prepare for location set-up (Preparation of bench space, request IT support on computer and network, request Facilities support on utilities), manage equipment delivery, installation, and set-up for use.
• Establish and manage a common model and contracting strategy across lab operations for equipment preventative maintenance/calibrations/repair, asset utilization, asset surplus redeployment, system upgrade, and retiring with customers, Lab Operations staff, and third-party vendors, to create and manage a list of equipment that is in use and also that scientists can have ready access to Lab Consumables & Critical Supplies.
• Work with laboratory staff and third-party vendors, to create and manage a master list of managed items onsite (by vendors and internally), stock locations, and stock levels to ensure that scientists have ready access to all basic consumables, critical materials.
• Partner with key stakeholders to develop and continuously strive for a proactive, high bar safety culture.
• Work with EH&S Manager to manage EH&S programs at the site to include, but not limited to, Incident Management, Ergonomics, Exposure Risk Assessments, Chemical Hygiene, Hazard Communication, Biosafety Management, Respiratory Protection, Hearing Conservation and Personal Protective Equipment (PPE), etc.
• Work with EH&S Manager to ensure the site is compliant with all environmental and safety regulations, including Federal, State and/or City regulations.

Requirements:

• Bachelor’s degree in science or engineering related discipline.
• 8-10 years of progressive experience in operational leadership in R&D and GMP/GLP laboratory, biotechnology or pharmaceutical environment.
• 3+ years of proven success leading teams of lab operations staff and vendors.
• Proven track record in managing and scaling lab operations.
• Understand laboratory supply streams, waste streams, and have experience working in an R&D and GMP and GLP laboratory environment.
• Is known for being 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.
• Ability to operate effectively at both an operational and strategic level.
• 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.
• Highly effective communication and organization skills.
• Proven collaboration and teamwork skills and experience in a fast-paced environment.
• 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.
• Proficiency planning and managing small projects.
• Proficient in GMP, GLP, and GDP.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Director, Facilities
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.