Validation Scientist - Clinical Central Laboratory
PPD - Pharmaceutical Product Development
This is an exciting opportunity to join our Central Laboratory in Zaventem in a newly created position. This new position will responsible for the validation process of new testing in the lab. Calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client. Routinely acts as the technical project leader for multiple projects, reviews and evaluates data, writes reports and protocols. Qualifies new instruments.
It’s essential that applicants experience in writing and resourcing materials for validation plans and summaries for use in clinical/diagnostic lab assays.
Education and Experience:
- B.S. in Chemistry, Biology, Biochemistry, Immunology or related science field and 3+ years new test validation or R&D experience in a CRO, clinical lab or regulated laboratory environment (not academia);
- Candidates with Medical Laboratory Scientist (MLS) accreditation or other ASCP certifications are highly preferred.
Knowledge, Skills and Abilities:
- Draft validation plans and validation reports for FDA approved verification and research use only (RUO) validation studies;
- Experience performing and writing validation plans and summaries for immunoassays, and automated chemistry urinalysis in a high throughput environment;
- Candidates with experience in regulated environments are highly preferred;
- Follow analytical method validation best practices guidelines including the Clinical & Laboratory Standards Institute (CLSI) and CAP/CLIA regulatory requirements;
- Ability to independently perform root cause analysis for method investigations;
- Working knowledge of common central laboratory instruments and operating systems;
- Strong ELISA knowledge;
- Proven problem solving and troubleshooting abilities;
- Proven ability in technical writing skills including writing SOPs;
- Time management and project management skills;
- Good written and oral communication skills;
- Candidates with high-throughput clinical laboratory experience in a research and development team are highly preferred;
- Additional clinical chemistry laboratory sub-specialties of interest include: molecular virology, microbiology, and flow cytometry.