Panda International

1 Job

113 Employees

About the Company

Behind every groundbreaking discovery in life sciences is a team of extraordinary people. At Panda, we connect that talent with organisations that are changing the world.

We are a Life Science recruitment consultancy specialising in biotechnology, medical devices, and pharmaceuticals where trust, expertise, and exceptional service are the foundation of everything we do.

Covering regional complexities whilst providing tailored talent solutions, we help clients and candidates meet their ambitions of both today and tomorrow.

Your organisation does extraordinary things every day. We help you find extraordinary people who make them happen.

Listed Jobs

Company Name: Panda International
Job Title: Analytical Validation Expert
Job Description: **Job Title:** Analytical Validation Expert **Role Summary:** Senior subject‑matter expert responsible for defining and governing analytical validation strategies for biopharmaceutical and advanced therapy medicinal product (ATMP) programs. Oversees GMP‑compliant method validation, method transfer, and quality assurance activities across MSAT, PAD, and QC laboratories while coaching teams and interfacing with clients and auditors. **Expectations:** - Minimum 5 years of senior experience in analytical validation/qualification. - MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related life‑sciences discipline. - Fluency in English (written and spoken). **Key Responsibilities:** - Develop and implement analytical validation and qualification strategy aligned with ICH Q2 and lifecycle validation principles. - Draft, review, and maintain GMP‑compliant documentation (protocols, reports, SOPs). - Lead method transfer activities (client → QC/PAD/internal) ensuring transfer efficacy and reproducibility. - Manage deviations, out‑of‑specification (OOS) events, and invalid results, providing root‑cause analysis and corrective actions. - Conduct technical reviews and make data‑driven decisions on validation data. - Serve as client contact for analytical strategies, release testing plans, and audit readiness. - Mentor and coach MSAT/QC teams on validation practices and GMP requirements. **Required Skills:** - Deep knowledge of EU GMP and FDA guidelines for cGMP analytical work in biopharma/ATMP. - Proficiency in analytical method validation (ICH Q2, lifecycle validation). - Experience with statistical assessment of validation data and Total Error approach. - Strong scientific writing, data review, and technical decision‑making. - Familiarity with Analytical Quality by Design (aQbD) concepts. **Required Education & Certifications:** - MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related field. - 5+ years of senior analytical validation experience; no specific certifications required.