Quality Control Analyst I

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 who will perform complex analytical testing for the release of drug products for clinical and commercial use. The role involves finished product testing, stability studies, and reporting QC results to management, plus supporting investigations, deviations, CAPA, and change requests as required by QC leadership.

You will participate in method validation or transfer, maintain documentation and records, support material

Qualifications

• Bachelor’s degree in life science required.
• Experience with mammalian cell culture and analytical assays.
• Proficient in Word, Excel, PowerPoint.
• Self-starter with ability to adapt to priorities.
• Strong scientific writing and communication skills.

Responsibilities

• Perform finished product testing and report QC results to management.
• Review analytical data and flag out-of-criteria data.
• Support laboratory investigations, CAPA, and change requests as required by QC leadership.
• Initiate and complete clinical laboratory investigations as needed.
• Assist in method validation or transfer.
• Maintain documentation and records, including record retention.
• Support material management and equipment upkeep in the QC lab.
• Participate in global audits and ensure an audit-ready lab space.

Skills

Mammalian Cell Culture

Plaque Titer

ELISA

qPCR

Southern Blot

Western Blot

Microsoft Word

Microsoft Excel

PowerPoint

Scientific writing

Communication skills

Self-starter

Education

Bachelor’s degree in life science

Tools

Microsoft Office Suite

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.

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will perform complex analytical testing for the release of drug products for clinical and commercial use.

Primary Responsibilities:

• Finished Product testing, stability testing, and reporting of the QC results to management.
• Review analytical data generated and notification to management if data is outside the prescribed acceptance criteria or specification
• Support laboratory investigations, deviation investigations, CAPA, and CR as required by QC Management
• Initiate and complete clinical laboratory investigations as required
• Participate in the execution of analytical method validation and/ or method transfer
• Support activities for Document Control and Record Retention
• Facilitate material management through material purchasing, receipt, inventory, storage, and sampling
• Maintain the equipment in the QC Lab though Equipment SOPs working with QC Supervisors
• Participate in QC Projects as needed and as instructed.
• Participate in all Global Audits as required
• Responsible for maintaining all QC Lab spaces in an Audit ready state
• Other duties as assigned

Experience and Skills Desired:

• Bachelor’s degree in life science required.
• Experience in the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot and Western Blot
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Environmental monitoring experience a plus but not required
• 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

Krystal Biotech, Inc. is an Equal Employment Opportunity and Aff… 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.