Quality Control Analyst III
Pittsburgh, PA
Full Time
Quality Control
Experienced
Quality Control Analyst III
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.
Responsibilities will include, but are not limited to, the following:
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative 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. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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.
Responsibilities will include, but are not limited to, the following:
- Finished Product testing, stability testing, 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.
- Lead laboratory investigations, deviation investigations, CAPA follow up and implementations, change control management including procedure and form revisions for both clinical and commercial products
- Participate in the execution of analytical method validation and/ or method transfer which may include technical writing of protocols and/or reports
- Responsible for Method data review and identifying OOT within products and analytical methods.
- Responsible for Reference Standard Program for all of QC
- Working cross functionally with other departments to implement improvements to CMC
- Review analytical data for compliance with regulations, methods and other specifications or criteria.
- 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
- Support activities for Document Control and Record Retention
- Facilitate material management through material purchasing, receipt, inventory, storage, and sampling
- Prepares applicable documents, forms, and records such as method forms, protocols, and work instructions following Good Document Practices.
- Other duties as assigned
- At minimum a Bachelor’s degree in life science required with 3+ years of laboratory experience
- Experience in the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, and Western Blot.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- A demonstrated self-starter who is highly motivated and able to address changing priorities.
- Strong communication stills with intra and inter departmentally.
- 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 Affirmative 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. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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