Stability Manager
About the job
- A master's or bachelor's degree and at least 8 years of industry experience in the pharmaceutical or biotechnology industry; 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 analytical methodologies, particularly for stability testing and assessment of biologics or vaccines.
- Understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia applicable to stability study design, expiry dating, and analytical method qualification and validation for biologics and vaccines.
- Hands-on experience applying basic statistical tools for stability data trending and rate analysis to support retest-period and shelf-life proposals.
- Attention to detail and skills in record keeping and documentation.
- Experience working in a regulated GLP or GMP environment.
- Extensive technical writing experience.
- Understanding of product development activities in biotech, drug, or vaccine development, including key interdependencies and proven development strategies and tactics.
- Ability to work globally with contract manufacturing organizations in different countries and continents.
- Design, coordinate, and execute stability studies for early- and late-stage vaccine products according to regulatory guidelines and company protocols.
- Summarize vaccine stability results using analytical testing expertise and statistical software such as JMP to perform statistical analyses and interpret data in accordance with regulatory standards.
- Create, implement, and manage stability databases; perform data trending and statistical analysis; forecast studies and testing; report metrics; and create, revise, and approve SOPs, stability protocols, and reports in accordance with current GMP, FDA, EU, global, and ICH guidelines and regulations.
- Produce PowerPoint presentations to communicate stability data to project team members; support project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.
- Author, review, revise, and approve SOPs, stability protocols and reports, memoranda, regulatory documents, and specification documents as required.
- Assist in leading the functionality and maintenance of stability-related processes and systems.
- Drive continuous improvement activities for clinical stability programs.
- Ensure the GMP stability program aligns with FDA, ICH, and other international agency requirements.
- Manage QC Stability quality-system records, including creating, assessing, and reviewing deviations, change controls, CAPAs, and other applicable stability-related investigations and events.
- Guide and work with others to identify continuous-improvement opportunities and implement and maintain solutions.
- Help establish a quality culture and shared accountability; ensure GMP compliance is built into process and system design and implementation, including tracking metrics to monitor and improve performance.
- Experience in IND, NDA, and BLA submissions is highly preferred.
- Strong interpersonal skills and the ability to communicate effectively verbally and in writing.
About the company
Vaxcyte develops broad-spectrum vaccines to prevent bacterial infections such as pneumococcal disease, Group A Strep, and Shigella. Using a proprietary cell-free protein synthesis platform called XpressCF™, the company attaches bacterial components to carrier proteins to trigger an immune response without the limitations of traditional cell-based manufacturing. This technology allows Vaxcyte to include more bacterial strains in a single dose than its competitors, as seen in their lead candidate which targets 24 different strains. The company's goal is to protect children and adults from life-threatening infections by creating vaccines that overcome complex bacterial defense mechanisms.
Company Size
501-1,000
Company Stage
IPO
Headquarters
San Carlos, California
Founded
2013
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Simplify's Take
What believers are saying
- All three OPUS adult Phase 3 trials fully enrolled by August 2026, de-risking execution.
- The FDA expanded VAX-31 Breakthrough Therapy designation in May 2025 to include pneumonia.
- Thermo Fisher’s up-to-$1 billion agreement and Lonza manufacturing build support commercial readiness.
What critics are saying
- VAX-31 OPUS-1 data shifted to October 2026, compressing launch timelines.
- Q2 2026 burn reached $284.3 million, while cash funding depends on dilution.
- Pfizer Prevnar 20 and Merck Capvaxive already control adult pneumococcal vaccination, threatening VAX-31 adoption.
What makes Vaxcyte unique
- Vaxcyte’s XpressCF platform produced VAX-31, a 31-valent PCV, on September 10, 2026.
- OPUS trials were finalized with FDA alignment for a planned BLA submission.
- Thermo Fisher and Lonza manufacturing deals lock commercial capacity across U.S. and Europe.
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0%Biotech stocks to consider - october 5th. Moderna, Vaxcyte, and Amgen are the three Biotech stocks to watch today, according to MarketBeat's stock screener tool. Biotech stocks are shares of publicly traded companies involved in developing and commercializing biotechnology products, such as pharmaceuticals, medical devices, diagnostics, and gene or cell therapies. For investors, these stocks can offer significant growth potential but often carry elevated risks due to clinical-trial outcomes, regulatory decisions, high research costs, and uncertain profitability. These companies had the highest dollar trading volume of any Biotech stocks within the last several days. Moderna (MRNA). Moderna, Inc., a biotechnology company, discovers, develops, and commercializes messenger RNA therapeutics and vaccines for the treatment of infectious diseases, immuno-oncology, rare diseases, autoimmune, and cardiovascular diseases in the United States, Europe, and internationally. Its respiratory vaccines include COVID-19, influenza, and respiratory syncytial virus, spikevax, and hMPV/PIV3 vaccines; latent vaccines comprise cytomegalovirus, epstein-barr virus, herpes simplex virus, varicella zoster virus, and human immunodeficiency virus vaccines; public health vaccines consists of Zika, Nipah, Mpox vaccines; and infectious diseases vaccines, such as lyme and norovirus vaccines. Discover more Shop Handbags View Collections Discover Luxury Vaxcyte (PCVX). Vaxcyte, Inc., a clinical-stage biotechnology vaccine company, develops novel protein vaccines to prevent or treat bacterial infectious diseases. Its lead vaccine candidate is VAX-24, a 24-valent investigational pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease. The company also develops VAX-31 to protect against emerging strains and to help address antibiotic resistance; VAX-A1, a novel conjugate vaccine candidate to prevent disease caused by Group A Streptococcus; VAX-PG, a novel protein vaccine candidate targeting keystone pathogen responsible for periodontitis; and VAX-GI to prevent Shigella, a bacterial illness. Amgen (AMGN). Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. The company's principal products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Otezla for the treatment of adult patients with plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet's disease; Prolia to treat postmenopausal women with osteoporosis; XGEVA for skeletal-related events prevention; Repatha, which reduces the risks of myocardial infarction, stroke, and coronary revascularization; Nplate for the treatment of patients with immune thrombocytopenia; KYPROLIS to treat patients with relapsed or refractory multiple myeloma; Aranesp to treat a lower-than-normal number of red blood cells and anemia; EVENITY for the treatment of osteoporosis in postmenopausal for men and women; Vectibix to treat patients with wild-type RAS metastatic colorectal cancer; BLINCYTO for the treatment of patients with acute lymphoblastic leukemia; TEPEZZA to treat thyroid eye disease; and KRYSTEXXA for the treatment of chronic refractory gout.
Vaxcyte announced its 31-valent pneumococcal vaccine, VAX-31, met all primary endpoints in a Phase 3 trial with 4,047 participants. The vaccine matched Pfizer's Prevnar 20 on all 20 shared serotypes and Merck's Capvaxive on 17 of 19 shared serotypes. Pfizer's Prevnar franchise generated $6.49 billion in 2025, representing roughly 10% of the company's $62.58 billion total revenue. The franchise grew just 1% last year, with Pfizer citing lower US market share. Merck's Capvaxive brought in $759 million in 2025, about 1% of its revenue. Pfizer trades at 9.87x forward earnings whilst Merck trades at 16.36x. Vaxcyte plans to file for approval in the first half of 2028. The company expects results from two additional trials in the first half of 2027.
Vaxcyte, a clinical-stage vaccine innovation company, has commenced underwritten public offerings of $500 million in common stock and pre-funded warrants, alongside $500 million in convertible senior notes due 2032. The company intends to grant underwriters a 30-day option to purchase an additional $75 million in each offering to cover over-allotments. The offerings are not contingent on each other and remain subject to market conditions. Jefferies, Leerink Partners, BofA Securities, and others are serving as joint book-running managers. Vaxcyte plans to use proceeds to fund clinical development of its VAX-31 adult and paediatric programmes, manufacturing scale-up, commercial investments for anticipated US launch, and research into early-stage pipeline vaccine candidates. The notes will accrue interest payable semi-annually and mature on 15 October 2032.
Vaxcyte's experimental pneumococcal vaccine VAX-31 met all main efficacy objectives in its first late-stage trial, sending shares soaring 50% and pushing the company's market value past $12 billion. The vaccine matched Pfizer's Prevnar 20 and Merck's Capvaxive in protecting against 28 bacterial strains and proved superior against three unique strains in adults aged 50 and older. VAX-31 was inferior on two strains using a stricter statistical threshold, though analysts called this a "near best-case scenario." Vaxcyte's shot targets the pneumococcal vaccine market worth $8 billion annually, dominated by Pfizer's franchise which earned over $6 billion last year. VAX-31 covers more than 30 strains, offering broader protection than existing vaccines. The company will report results from two additional late-stage trials next year before seeking regulatory approval.
Vaxcyte claims success in bid to beat Pfizer and Merck in lucrative vaccine market. Biotech company's pneumococcal vaccine hit primary endpoints in late-stage study. Oct. 5, 2026 General Assignment Reporter Vaxcyte said Monday that its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up the California-based biotech to compete with Pfizer and Merck. Vaxcyte's shot, VAX-31, is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer's Prevnar and 21 strains for Merck's Capvaxive. In the trial, just over 3,500 adults age 50 and older were randomized to receive VAX-31, Prevnar, or Capvaxive. Investigators then measured the strength of their antibody responses against different strains.