Director: Immunology & Large Molecule Bioanalysis

Overview

• Responsible for bioanalytical strategies (PK, ADA, ELISPOT, Flo Cytometry, etc), methods, data and documents for all Lovelace Biomedical programs, both internal and external
• Develops and manages related fiscal budgets, staffing, and planning processes
• Ensure delivery of high-quality bioanalytical data and regulatory documents (IND, BLA, global filings) as well as health authority interactions and scientific contributions
• Ensure regulatory compliance and scientific oversight of internal as well as external bioanalytical programs
• Ensure new bioanalytical technologies are being assessed and incorporated when appropriate.
• Provide mentoring and career development of staff, and other employees as requested
• Collaborate effectively with various stakeholders throughout the company including global partners
• Leads project teams, and cross functional initiatives as needed
• Participates in scientific leadership and direction for the Scientific Core Labs
• Presents data, collaborative findings, and plans to management, partners and collaborators, as well as at conferences and regulatory meetings as appropriate
• Manages external contractor sites at all stages and in regard to all technical aspects and assists quality assurance/regulatory functions for bioassay activities
• Coordinates and facilitates advancement of internal objectives including RFPs, proposals, reports and regulatory documents
• Performs review and, when necessary, additional analyses, of data generated by vendor laboratories
• Authors internal reports
• History of conducting and overseeing the analysis of clinical and nonclinical samples for all therapeutic programs in a GLP laboratory.
• Manages the generation, qualification and distribution of key reagents

Qualifications

• Proven ability to manage bioassay development, optimization and qualification within a CRO or with CRO partners
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Solid knowledge of GLP practices for bioanalytical laboratories and familiarity with ICH, FDA and EMA guidance, as well as USP and industry suggested best practices, regarding bioassay advancement and management
• Experience in direct interactions and communication with regulatory and health authorities (FDA, EMA, etc.)
• Experience in authoring and reviewing critical documentation critically reviewed new technical documents, protocols and reports connected to assay development, validation and clinical sample testing, biomarker elements in IND filing documents.
• Experience in guiding technical development and troubleshooting of bioassays at CRO partners through email communication, teleconferences and on-site visits
• Experience training and developing advanced scientific personnel
• Experience across all phases of large molecule drug development required, experience in gene therapy or stem cell therapy drug development preferred
• The individual must have excellent inter-personal and communication skills, and the ability to lead and work with others in a positive and collaborative manner to set and meet organizational goals
• Experience overseeing method development, method transfer, and method cross validation is a plus
• Accustomed to working in a fast-paced, dynamic environment
• Ability to work collaboratively with stakeholders to resolve issues
• Skills demonstrating initiative and creativity are also essential
• Expertise in gene and cell-based therapy, immunology, infectious diseases, neuroscience or oncology therapeutic areas is preferred

Salary