Process Validation Specialist
3 months ago
Krystal Biotech is a pioneering genetic medicine company that leverages its proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. With a strong focus on patient-centricity, the company is committed to delivering innovative treatments that address high unmet medical needs.
As a Process Validation Associate, you will play a critical role in supporting the development and implementation of process validation strategies for our gene therapy products. This includes collaborating with cross-functional teams to ensure upstream and downstream processes are well-controlled, applying QbD and traditional process validation principles, and performing risk assessments to identify gaps in process understanding.
Key Responsibilities:
- Partner with Process Development and Manufacturing to ensure seamless process transitions.
- Develop and execute process validation plans, including risk assessments and process improvements.
- Collaborate with CMC counterparts to draft materials for agency review.
- Implement a continuous improvement mindset to drive process efficiency and effectiveness.
- Develop and maintain high-quality documentation that meets applicable standards.
Requirements:
- Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or related field.
- Relevant validation and/or engineering experience in the Biotech or Pharmaceutical industry (1+ year for Associate, 3+ years for Engineer level).
- Strong knowledge of GMP and ICH requirements, as well as QbD principles.
- Excellent communication and collaboration skills, with the ability to work effectively in a fast-paced environment.
Krystal Biotech is an Equal Employment Opportunity and Affirmative Action Employer.
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