Stability Manager

Vaxcyte, Inc; San Carlos (CA); On-site; USD 147,000 - 171,000; Full time

Job summary

Vaxcyte, Inc in San Carlos is searching for a Stability Manager within their Vaccine Product Development organization. This role involves overseeing the stability program for vaccine projects, requiring a strong background in analytical methodologies and vaccine stability principles.

The ideal candidate will have over 8 years of experience in the biopharmaceutical industry, with expertise in regulatory guidelines, stability testing, and technical writing. A comprehensive benefits package and competitive salary range of $147,000 – $171,000 are offered.

Qualifications

• Minimum of 8 years of industry experience in Pharma/Biotech.
• Strong understanding of degradation pathways and shelf-life determination.
• Experience in IND, NDA, and BLA submission preferred.

Responsibilities

• Manage stability program for various vaccine projects.
• Design and execute stability studies according to regulatory guidelines.
• Produce presentations to communicate stability data effectively.

Skills

Analytical methodologies

Statistical analysis

Vaccine stability principles

Attention to detail

Interpersonal skills

Education

MS or BS in relevant field

Tools

JMP

Job description

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

Core Values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary: Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Stability Manager within the Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development.

Essential Functions:

• Designs, coordinate, and execute stability studies for early and late-stage vaccine products according to regulatory guidelines and company protocols.
• Summarize vaccine stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
• This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, study and testing forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
• Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.
• Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).
• The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
• Drives continuous improvement activities for the clinical stability programs.
• Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
• Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
• Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

Requirements:

• MS or BS with minimum of 8 years of industry experience in Pharma / Biotech industry required. Other combinations of education and/or experience may be considered.
• Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
• Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or vaccines.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
• Solid understanding and hands‑on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf‑life proposals.
• Attention to detail and excellent skills in record keeping / documentation.
• Experience in IND, NDA and BLA submission is highly preferred.
• Experience working in a regulated (GLP / GMP) environment.
• Extensive technical writing experience.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Ability to work globally with CMOs in different countries and continents.

Reports to: Director, Stability

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

Salary Range: $147,000 – $171,000 (SF Bay Area). Salary ranges for non-California locations may vary.

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.