Principal Scientist

6 days ago

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Apellis Pharmaceuticals

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Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000

Description

• We are seeking a talented and highly motivated individual to join the DMPK/Bioanalysis group at Apellis Pharmaceuticals in Waltham, MA. • The main responsibility for this position is to outsource and manage non-clinical and clinical PD (biomarker) bioanalysis. • This includes managing novel PD method development and validation for various molecules and matrices, being responsible for providing the PD results for clinical database locks, auditing and monitoring the specialty labs. • This position will work to streamline and advance the research-grade bioanalytical methods at the in-house lab and facilitate the transition to external specialty labs for both nonclinical and clinical PD sample analysis. • This individual must own the role as PD BA expert at Apellis, work well independently, and should have a passion and track record of successful LBA method development. • The role will require literature research, and interactive and effective communication to provide biomarker strategy and sample collection guidance for PD samples.

Requirements

• PhD in Biology, Chemistry or related field with 5+ years of LBA experience • MS in Biology, Chemistry or related field with 10+ years of LBA experience • BS in Biology, Chemistry or related field with 15+ years of LBA experience • Strong understanding of the bioanalytical method development / validation, clinical studies process, sample management and regulatory submissions is required • Significant experience managing specialty labs is required • Experience with GxPs and quality management systems is required • Strong understanding of the drug discovery and development process

Benefits

• Apellis offers a great benefit package which includes: health insurance with full premium coverage • 401K with company match • paid time off (PTO) • long-term disability insurance • life insurance and more!