Quality Control Laboratory Analyst (Raw Materials)

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated Quality Control Analyst responsible for in-house raw materials and product testing used in manufacturing clinical and commercial drug products. The role emphasizes cGMP compliance, data review, and rigorous documentation.

The candidate will ensure SOPs are followed, participate in investigations, and support equipment qualification and calibration to maintain quality standards across the QC lab.

Qualifications

• Bachelor’s degree in life sciences required.
• Experience with pH, Osmo, Endotoxin, Appearance testing preferred.
• Ability to follow SOPs and work in a GMP environment.

Responsibilities

• Perform cGMP material inspection and testing for drug product manufacturing.
• Review analytical data for regulatory compliance and collaborate when criteria aren’t met.
• Initiate and update QC documentation, including SOPs and test methods.
• Maintain QC lab equipment and coordinate calibration/maintenance.
• Support Document Control and Record Retention activities.

Skills

cGMP testing

SOP adherence

Data review

Documentation

Laboratory teamwork

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

About Krystal Bio:

At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Position Overview:

Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will be responsible for in-house raw materials and product testing for the use in the manufacture of clinical and commercial drug products.

Primary Responsibilities:

• Perform cGMP material inspection for all materials utilized for drug product manufacturing.
• Perform cGMP material testing for all materials needed for further use in manufacturing process.
• Review analytical data for compliance with regulations, methods and other specifications or criteria and collaborate with management when data does not meet acceptance criteria.
• Participate in laboratory investigations, quality event investigations, protocol and report development.
• Initiate and update quality control documentation, such as SOPs, material monographs (specification and testing documents), and test methods.
• Support activities for Document Control and Record Retention.
• Implementation of USP Quality Standards and verification of USP Methods.
• Maintain equipment in the QC Lab by performing and coordinating equipment qualification, calibration, and preventive maintenance.
• Other duties as assigned.

Requirements and Preferred Qualifications:

• Bachelor’s degree in life sciences or equivalent.
• Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture, and FBS testing, preferred.
• Demonstrated experience in laboratory environment and ability to follow SOPs.
• A demonstrated self-starter who is highly motivated and able to address changing priorities.
• Ability to take a proactive approach on the job with the ability to work with a dynamic team.
• Excellent scientific writing, other written and oral communication skills are required.
• Proficient in Microsoft Word, Excel and PowerPoint.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affimative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.