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Quality Assurance Process Associate

2 months ago

Pittsburgh, Pennsylvania, United States Krystal Biotech Full time
Job Overview

About Krystal Biotech:

At Krystal Biotech, we unite exceptional talent and passionate individuals to advance the discovery, development, manufacturing, and commercialization of genetic therapies aimed at addressing significant unmet medical needs.

Established in 2016, Krystal stands out through three key elements: our innovative gene therapy platform, state-of-the-art manufacturing capabilities, and a distinctive commercialization approach that prioritizes the patient experience.

Krystal has achieved U.S. FDA approval for VYJUVEK, the first and only redosable gene therapy for Dystrophic Epidermolysis Bullosa (DEB). We continue to leverage our proprietary platform to expedite a diverse pipeline of investigational genetic therapies across various fields including respiratory, oncology, dermatology, and ophthalmology.

Headquartered in Pittsburgh, PA, Krystal operates two advanced CGMP manufacturing facilities and has teams globally, with additional offices in Switzerland, Germany, and Japan. Our organization is driven by individuals who are dedicated, embrace challenges, and uphold the highest standards of scientific integrity. As we expand, we seek team members who reflect these values.

Position Summary:

Krystal Biotech is in search of a driven Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) to assist in the planning, design, and execution of process validation activities. This role involves conducting risk assessments, implementing process enhancements, and managing various projects. The individual will also be crucial in facilitating technology transfer and ensuring effective process transitions across sites.

Key Responsibilities:

  • Collaborate with Process Development and Manufacturing teams to ensure effective control of upstream and downstream processes.
  • Utilize Quality by Design (QbD) and traditional validation methodologies for both existing and new gene therapy products.
  • Conduct and document risk assessments to capture current process knowledge and identify potential gaps.
  • Execute experiments at both bench and manufacturing scales to enhance process understanding and support development initiatives.
  • Address process and equipment challenges to promote operational efficiencies.
  • Foster a culture of continuous improvement within processes and departments.
  • Create high-quality documentation that adheres to applicable standards and is suitable for its intended purpose.
  • Contribute to the development of new manufacturing facilities to ensure seamless technology and process transfers.
  • Collaborate with CMC counterparts to prepare materials for regulatory review.

Minimum Qualifications & Desired Skills:

  • Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or a related field.
  • Relevant validation and/or engineering experience in the Biotech or Pharmaceutical sector (1+ years for Associate, 3+ years for Engineer level).
  • Knowledge and experience in GMP, GLP, and statistical analysis.
  • Strong understanding of GMP and ICH guidelines, as well as QbD principles.
  • Prior experience in the gene therapy sector is preferred.
  • Self-motivated with the ability to work independently.
  • Capable of managing multiple responsibilities in a dynamic environment and prioritizing tasks effectively.
  • Excellent verbal and written communication skills.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. Qualified candidates will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, or disability status.

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