Director, QC and Stability / Reference Program

Location
Foster City, CA, United States
Posted
Feb 23, 2021
Ref
503833104
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
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 w e 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 preclinical, 24 - valent broad - spectrum pneumococcal conjugate PCV with precl inical 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 individual to join Vaxcyte 's Vac cine Product Development organization as a Director within Analytical Development and QC (ADQC) . The primary function of t his director level position is to oversee the QC activities and compliance such as analytical method transfer to the CMO, the method validation and release and stability testing. The person will also be the functional decision maker for QC, stability and reference standard program strategic decision s, and serve as a key contributor for company long term growth. This position reports directly to the Senior Director of Analytical Development and QC (AD&QC). The successful candidate will also provide mentorship and GMP compliance guidance for the ADQC department.

Essential Functions:

• Oversee Vaxcyte QC, stability program and reference standard program.
• Ensure quality and compliance of QC activities, and accountable for timely deliverables of the analytical method transfer , implementation and validation at CMO s , as well as stability studies, expiry dating/shelf life of raw material, intermediates, d rug substance and drug products and reference standard qualification.
• Serve as decision maker for QC, stability and reference standard program, provide clear rationale and thorough supporting data to gain the CMC team endorsement of the decision.
• Evaluate and audit CMOs for QC release testing and stability studies, provide recommendation to CMC team for QC site selection of various programs from e arly to late clinical phases
• Design and implement team structure and growth plan to meet the company short term business needs and support company long term growth plan.
• Manage performance of the team to ensure alignment towards goals; set SMART goals for the team members; ensures teams have the right mix of talent and resources to meet/exceed goals
• Develop, implement and ensure compliance of the SOPs for stability program
• Establish phase appropriate reference standard program and ensure its compliance to industry guidance and HA regulations. meets compliance to health authority expectation
• Collaborate with Analytical Develop Scientists, Formulation, Process Development, Conjugation to gain the necessary method and product knowledge
• Review analytical method development data, reports and method document to be transferred to CMOs
• Review and approve all QC related deviation, CAPA and their associated investigation reports.
• Author relevant regulatory submission and address health autho rity questions for IND approval
• Manage relationships with existing and new CMOs, manage timelines and cost for the analytical method transfer, method qualification/validation and stability studies

Requirements:

• MS or BS with 20+ years of industry experience in Pharma / Biotech industry required
• Demonstrate sound complex decision making skills and exhibit good judgment. Make decision with understanding of the strategic context and short and long term impact of decisions on other departments or functional a reas b efore making them; able to decide and act effectively without having the whole picture;
• Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements "best practices" or leading - edge quality standards;
• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line - management
• Track record of building strong functional team, able to leverages understanding of strengths and weaknesses of team members in positioning them in the team; ability to anticipate and implements changes in roles and accountabilities in response to changes in the work environment; en sures teams have the right mix of talent and resources to meet/exceed goals;
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tac tics
• Expert analytical skills for integrating and interpreting interdisciplinary project information; thorough understanding of the drug/vaccine development process
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to ana lytical method qualification/validation for small molecules, biologics and vaccines, stability study design and expiry dating
• Demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical transfe r, validation and stability strategy
• Ability to work globally with CMOs in different countries and continents
• U nderstanding of various analytical chemistry methodology principles and successful track record of method transfer, trouble shooting and validation for GMP release and stability testing, as well as stability study design and expiry/shelf life establish ment
• Self -starter and resourceful problem solver, able to move up learning curve independently and map out intermediate milestones to achieve project goals.
• Experience in IND, NDA and BLA submission is highly preferred
• Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats
• Ability to work in a fast - paced, cross - functional environment and collaborate effectively with other team members

Reports to: Senior Director, Analytical Development & Quality Control

Location: Foster City, CA

Compensation:

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