What are the responsibilities and job description for the Validation Specialist Sr. Scientist position at Aldevron?
About Aldevron
">At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.
Our Quality and Regulatory Affairs Department is seeking a highly skilled and experienced Senior Scientist to join our Analytical Method Validation team.
">Key Responsibilities
">- Represent the Analytical Method Validation team as a subject matter expert (SME) on analytical test method validation, test method transfer, and lead test method continuous improvement initiatives as part of the analytical procedure life cycle.
- Collaborate with cross-functional internal teams as well as clients to ensure test methods utilized at Aldevron are qualified/validated in accordance with the appropriate current regulatory expectations, in a phase-appropriate manner.
- Evaluate new testing applications and instrumentation, and act as the Analytical Method Validation representative in the assessment of new testing applications.
- Provide technical expertise as an analytical SME in deviation investigations (e.g., Out of Specification (OOS), Quality Events), and assist in identifying root causes and developing Corrective Actions and Preventative Actions (CAPA).
- Collaborate with department leadership to identify gaps and propose solution-based approaches for continuous improvement, ensuring the Analytical Method Validation team meets the company's priority projects.
- Mentor and train Analytical Method Validation Associates in test method validation principles and strategies, including phase-appropriate validation approaches.
Requirements and Qualifications
">- PhD with 5 years of experience, MS degree with 7 years of experience, or BS degree with 10 years of experience in a relevant field.
- Proven competency in test method validation, transfer, and development, demonstrated through publications or previous experience.
- Strong understanding of FDA, EU, and ICH regulations related to test method validation, transfer, and development.
- Hands-on experience in validating test methods for nucleic acids (mRNA, DNA) and/or protein products.
- Proficiency in analytical techniques such as HPLC, ELISA, capillary electrophoresis, and PCR.
About Us
">We accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
">We are one of 10 Life Sciences companies of Danaher, and together, we make a difference in people's lives.
