Bioanalysis Director

SUMMARY/JOB PURPOSE: The Bioanalysis Director (BD) will manage GxP-compliance in bioanalytical work for pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers in support of nonclinical and clinical studies. BD will manage CRO-outsourced bioanalysis for small molecules and biologics and provide project management support for external and internal projects. BD will partner with other functional leaders in Quality Assurance, Compliance, Quality Management & Biosamples (QMB) to ensure project quality and timely delivery. ESSENTIAL DUTIES AND RESPONSIBILITIES: Manage a GxP-compliant Bioanalytical Lab and support Lab Operations & Processes Manage critical reagents inventory/shipments, study samples custody/logistics and analytical instruments maintenance/validation Lead GxP-compliance for PK, ADA, and biomarker bioanalysis for nonclinical and clinical trials Serve as GxP SME and group representative for interactions with QA, QMB, EHS and CROs Author and review standard operating procedures (SOP), qualification/validation protocols and bioanalytical reports Manage and oversee CRO-outsourced bioanalysis of small molecules and antibody-drug candidates (ADCs) Serve as project manager for timelines and budgets in support of internal and outsourced projects Contribute to regulatory interactions and filings SUPERVISORY RESPONSIBILITIES: Will supervise 1 or 2 direct reports EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS degree in biological science or related field and a minimum of 13 years of relevant work experience; or, MS degree in biological science or related field and a minimum of 11 years of relevant work experience; or, PhD degree or equivalent in biological science or a related discipline and a minimum of 8 years of relevant work experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Experience/expertise in regulated bioanalysis and clinical-stage programs Knowledge and experience in GLP/GCP requirements and practices in bioanalytical lab Experience with LCMS methods for small molecules and ADCs, experience with hybrid-LCMS is a plus Prior experience and good understanding of the regulatory requirement for method development and validation for PK, immunogenicity and biomarkers Experience in managing CRO-outsourced bioanalysis Experience with project management Experience with regulatory interactions is a plus Knowledge/Skills: Applied knowledge and expertise with GLP and GCP regulations High level of expertise in bioanalytical methods and technology platforms, including immunoassays and LCMS methods Proficiency with Microsoft office software (Word, Excel, PowerPoint) and graphical computer programs (e.g., GraphPad, etc.). Detail-oriented, good organizational, documentation, and technical writing skills. Able to work collaboratively with people from a broad range of business functions Excellent interpersonal, organization and communication skills JOB COMPLEXITY: Applies working knowledge of scientific, technical and quality management principles to solve problems (assays, processes, equipment, etc.). Work on a diverse scope of problems including scientific, technical, operational and compliance Must be able to function under minimum supervision DISCLAIMER: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. #J-18808-Ljbffr