Full-Time
Quality Assurance Associate
Krystal Biotech
201-500 employees
Dermatology-focused topical gene therapies
No salary listed
Pittsburgh, PA, USA
In Person
Bachelor's
 QA & Testing (1) |
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- A minimum of a Bachelor's Degree in Biology or a related Life Science with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry.
- Knowledge or experience in Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice.
- Strong knowledge of Good Manufacturing Practice and International Council for Harmonisation requirements.
- Ability to work independently with minimal oversight.
- Ability to handle multiple roles, work in a fast-paced and changing environment, and prioritize activities appropriately.
- Excellent oral and written communication skills.
- Work with internal teams to obtain an understanding of the product and the documentation requirements.
- Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
- Develop expertise on Food and Drug Administration regulations and audit processes.
- Initiate and update Good Manufacturing Practice manufacturing-associated documentation, such as clearing procedures.
- Provide oversight of daily quality assurance functions, including review and approval of records generated by manufacturing and quality control documents.
- Support updates to standard operating procedures and associated forms.
- Assist with quality assurance efforts for site current Good Practice documentation related to the operation of gene therapy manufacturing.
- Ensure compliance with regulatory agencies and oversee continuous improvement of the company's quality assurance and compliance functions.
- Experience with FDA audits.
Krystal Biotech develops and sells gene therapies for rare dermatological diseases. Its lead product, VYJUVEK (beremagene geperpavec-svdt), is a topical gene therapy designed to treat dystrophic epidermolysis bullosa (DEB) by delivering a corrected gene directly to the skin so that damaged skin can heal. The company’s STAR-D platform enables off-the-shelf gene therapies that can be used across a range of skin conditions and the VYJUVEK therapy is designed to be redoable, meaning its treatment can be repeated if needed. Krystal Biotech stands out by owning exclusive worldwide rights to its therapies and by being the first FDA-approved medicine for DEB, a rare condition. The company’s goal is to grow its portfolio of dermatology gene therapies using the STAR-D platform to provide accessible, repeatable treatments for patients with rare skin diseases.
Company Size
201-500
Company Stage
IPO
Headquarters
Pittsburgh, Pennsylvania
Founded
2016
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Simplify's Take
What believers are saying
- Q2 2026 VYJUVEK revenue reached $119.2 million, up 24% year over year.
- Krystal ended Q2 2026 with over $1.1 billion cash, financing launches and trials.
- UK approval on May 15, 2026 and Italy, Spain launches target 2H 2026 expansion.
What critics are saying
- VYJUVEK still funds everything; a 2027 slowdown would expose Krystal’s single-product concentration.
- Germany’s pricing reserve already flattened international revenue in Q2 2026; a bad settlement hits margins.
- KB801 and KB803 need positive 2026 readouts; failures would crush the pipeline and valuation.
What makes Krystal Biotech unique
- VYJUVEK remains the first FDA-approved redosable topical gene therapy for DEB, still on August 3, 2026.
- Krystal’s STAR-D platform targets off-the-shelf dermatology and eye programs without individualized manufacturing complexity.
- The company couples commercial scale with rare-disease payer adoption, surpassing 730 U.S. reimbursement approvals.
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Growth & Insights and Company News
6 month growth
↓ -2%1 year growth
↓ -2%2 year growth
↑ 0%Krystal Biotech reported second-quarter 2026 revenue of $119.2 million from global sales of VYJUVEK, up 24% year over year. US sales reached $91.6 million, whilst net income rose to $54.8 million, or $1.79 per diluted share, from $38.3 million a year earlier. The company ended the quarter with over $1.1 billion in cash and investments. It has secured more than 730 US reimbursement approvals and is expanding outreach to community settings to reach potentially undiagnosed patients. European and Japanese revenue growth was constrained by a German pricing reserve, with negotiations expected to conclude in the third quarter. The company maintained its full-year 2026 expense outlook of $175 million to $195 million. Multiple pipeline milestones are approaching, including results from the IOLITE study of KB803 expected later this year.
Krystal Biotech reported second-quarter 2026 earnings that beat expectations but missed on revenue, sending shares down 7.65% in pre-market trading. The company posted adjusted earnings of $1.79 per share, exceeding the $1.70 consensus estimate. Product revenue reached $119.2 million, below the $122.3 million forecast, though up 24% from $96 million a year earlier. Net income rose to $54.8 million from $38.3 million in the prior-year quarter. The company reported a 95% gross margin for VYJUVEK, its flagship product, which secured over 730 reimbursement approvals and is prescribed by more than 640 healthcare providers. Krystal ended the quarter with approximately $1.1 billion in cash and investments. Commercial launches in Italy and Spain are expected before year-end.
Krystal Biotech reported $119.2 million in global VYJUVEK revenue for the second quarter of 2026, a 24% increase year-over-year. The gene therapy for dystrophic epidermolysis bullosa has generated $965.9 million since launch, with a gross margin of 95%. The company has secured over 730 reimbursement approvals in the United States and expanded to more than 640 prescribers. VYJUVEK continues gaining traction in Germany, France, and Japan, with launches planned in Spain and Italy later this year. The UK approved VYJUVEK in May, and pricing discussions are underway. Additional marketing applications are expected in Switzerland and Australia during the second half of 2026. Krystal ended the quarter with $1.1 billion in cash and investments. The company is advancing multiple clinical programmes across eye, lung, and skin conditions.
Krystal Biotech's share price rose 7.9% following its promotion from the S&P 600 to the S&P 400 index earlier this month. The biotechnology company also joined the S&P 400 Health Care and Biotechnology indices. Additionally, Krystal filed a response with the US Patent and Trademark Office containing single-patient data from its investigational KB801 gene therapy for neurotrophic keratitis. The company noted the data showed complete closure of a persistent corneal epithelial defect in one patient from a discontinued study. Krystal emphasised the early-stage nature of the data and said it should not be used to draw efficacy conclusions. The index inclusion increases the company's exposure to mid-cap index funds. Analysts expect Krystal's investment case remains focused on its VYJUVEK rare disease franchise and upcoming pivotal data across its gene therapy pipeline.
Brown Capital Management's Small Company Fund added Krystal Biotech, Inc. (NASDAQ:KRYS) to its portfolio in the first quarter of 2026, according to its investor letter. The commercial-stage gene therapy company develops treatments for rare skin disorders using topical, re-dosable gene therapy. Krystal's lead product, VYJUVEK, is the first FDA-approved topical gene therapy for dystrophic epidermolysis bullosa. The treatment has exceeded commercialisation expectations with rapid patient adoption and strong payer acceptance, generating gross margins near 94%. The company reported $389 million in revenue for 2025 with a 42% operating margin. Brown Capital expects approximately 30% annual revenue growth and operating margins rising to 50% in coming years. The fund cited Krystal's recession-resistant revenue stream and expansion into European and Japanese markets as key investment drivers.