Senior Quality Control Analyst

Pittsburgh, PA
Full Time
Quality Control
Experienced

Senior Quality Control Analyst 

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

 

 

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated and experienced Senior Quality Control Analyst who will perform routine testing for in process, drug product, and raw materials samples. 

Specific responsibilities include but are not limited to:

  • Maintain cell cultures for Quality Control department in support of analytical methods
  • Prepares reagents in support of cell-based bioassays and binding ELISA assays using aseptic technique and good material handling practices
  • Performs routine testing and enters data into Laboratory Information Management System to ensure compliance with standards; reports any quality anomalies
  • Performs equipment cleaning and maintenance
  • Maintains laboratory supplies through inventory and stocking and laboratory cleanliness
  • Completes laboratory documentation and reviews logbook data
  • Complies with all pertinent regulatory agency requirements
  • Participates in required training activities
  • Calibrates or verifies calibration of instruments/devices prior to use
  • Participate in laboratory investigations, deviation management, protocol and report development and review
  • Other duties as assigned

Experience and Skills Desired:

  • Bachelor’s degree in life science or relevant engineering discipline, required
  • 3+ years of industry-relevant QC experience in a GMP setting
  • 5+ years of laboratory experience with the following techniques: Plaque Titer, ELISA, qPCR, Southern Blot and Western Blot
  • Proficiency in mammalian cell culture required
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • 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. 

 

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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