Key Responsibilities:
- Propose assay design and/or strategy, develop, validate, conduct, and troubleshoot bioanalytical methods for biological sample testing and data reporting. Present and interpret data internally and/or externally as needed.
- Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
- Serve as Subject Matter Expert (SME) for one or more of the following assay platforms: LBA (ELISA & Meso-Scale Discovery (ECL)), Cell-Based Assays, qPCR, dPCR, FLOW Cytometry, ELISpot, LCMS, ImmunoAffinity-LCMS, etc.).
- Author and/or review key regulatory documents, study plans, laboratory data, and technical reports.
- Assist with oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
- Assist in establishing and improving policies, procedures, work instructions and SOPs.
- Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
- Perform other related duties as assigned.
Qualifications & Educational Requirements:
- Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(Ph.D.), 9+(Master’s) or 12+(Bachelor’s) years of Pharma/Biotech/CRO experience.
- Good knowledge and hands on experience on regulated bioanalysis.
- GLP/GCLP experience preferred.
- GDP experience preferred.
- Supervisory experience in both project and talent (people) management is preferred.
- Ability to work independently and pay good attention to details.
- Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
- Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
- Effective writing and communication skills.
Location: Germantown, MD
Position Type: Full-Time