Quality Control Analyst I

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); In loco; USD 60.000 - 85.000; Tempo pieno

Descrizione del lavoro

Krystal Biotech, Inc. is seeking a highly motivated Quality Control Analyst I to perform complex analytical testing for release of drug products for clinical and commercial use. You will support investigations, CAPA, and maintain QC lab readiness.

Responsibilities include finished product and stability testing, data review, and involvement in method validation and transfers. A life science degree and lab experience are required for this role in a fast-paced biotech environment.

Competenze

• Bachelor’s degree in life science required.
• Experience with mammalian cell culture and common analytical assays.
• Strong written and verbal communication; detail oriented.

Mansioni

• Perform finished product and stability testing and report results to management.
• Review data and notify management if data fails acceptance criteria.
• Support CAPA, deviation investigations, and quality systems.
• Participate in analytical method validation and method transfer.
• Maintain QC lab spaces and participate in audits.

Conoscenze

Mammalian Cell Culture

Plaque Titer

ELISA

qPCR

Southern Blot

Western Blot

Environmental monitoring

Formazione

Bachelor’s degree in life science

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Descrizione del lavoro

Quality Control Analyst / Specialist I

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 through 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.