Director: Immunology & Large Molecule Bioanalysis

The Senior Scientist and Director of Immunology and large molecule bioanalysis will be a highly motivated individual with a proven track record of scientific, leadership, collaboration work, and management experience who plays a key leadership role in the Bioanalytical Sciences Division of the Scientific Core labs. The Senior Scientist will provide scientific, technical, strategic leadership and oversight of the Immunology and large molecule bioanalysis deliverables. More specifically, the position will focus on large molecule bioanalysis, supporting assay development, validation and sample analysis for PK, immunology, toxicology and ADA projects. Experience in assays to support gene and cell-based therapy (neutralizing antibodies, immunogenicity assays). The Senior Scientist will apply their hands-on experience in method development and validation, as well as experience in sample analysis, to lead a team of technical/scientist staff. The Senior Scientist will be expected to contribute to the authoring and compiling of key regulatory documents as well as possible communications with regulatory and health authorities (FDA, EMA, etc.). The Senior Scientist will be responsible for a budget unique to each engagement and will allocate and manage team resources to achieve both internal and external goals and objectives within the allotted budget.

Responsibilities:

• 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

Requires a Ph.D. in Immunology, Pharmaceutical Sciences, Molecular Biology, Cell Biology or a related discipline and a minimum of 10 years of directly-related experience; or equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained. A minimum of 5 years of managerial experience, preferably in a CRO, is required.

Requires:

• 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 is commensurate with experience.