The Director of Ligand Binding Assays provides scientific, operational, and strategic leadership for Celerion's U.S. LBA organization, with primary responsibility for the growth and success of the Phoenix laboratory and leadership oversight of LBA activities in Lincoln, Nebraska. This role is responsible for building high-performing teams, driving scientific excellence, ensuring regulatory compliance, achieving business objectives, and delivering exceptional client service. The Director will partner closely with Bioanalytical Services leadership and cross-functional teams to support growth, innovation, and operational excellence. Additionally, this role provides broader operational leadership at the Phoenix site through collaboration with Molecular & Cell-Based (MCB), Dose Formulation Analysis (DFA), and other functional groups.
Leadership & Operations
Provide leadership for Celerion's Ligand Binding Assay teams across Phoenix and Lincoln by building a high-performing, collaborative organization focused on scientific excellence, accountability, and continuous improvement. This role is responsible for developing talent through coaching, performance management, and succession planning while ensuring the laboratory has the people, resources, capacity, and technology needed to meet growth objectives. The Director also oversees operational performance, ensuring revenue, quality, productivity, and client timelines are consistently achieved.
Scientific Leadership
Serve as the senior scientific leader and subject matter expert for ligand binding bioanalysis, providing oversight for the development, validation, transfer, and execution of bioanalytical methods supporting biologics and other large-molecule therapeutics. The Director will ensure studies are scientifically sound, compliant with regulatory expectations, and aligned with client needs while driving innovation through new technologies, automation, and process improvements.
Quality & Compliance
Lead a culture of quality and compliance by ensuring all laboratory activities are performed in accordance with GLP, GCP, EHS, and applicable regulatory requirements. The Director is accountable for maintaining inspection readiness, supporting audits, promoting right-first-time execution, and partnering with Quality Assurance and operational teams to continuously improve processes and quality systems.
Business & Client Engagement
Partner with Business Development and senior leadership to support growth initiatives, evaluate new opportunities, and strengthen client relationships. The Director serves as a scientific advisor during client interactions, capability presentations, and proposal development, helping to deliver solutions that meet client objectives while contributing to customer satisfaction, retention, and long-term business success.
Industry Leadership
Represent Celerion as a leader within the bioanalytical community by participating in professional organizations, industry collaborations, conferences, and scientific publications. The Director will stay informed on emerging technologies, regulatory developments, and industry trends, utilizing this knowledge to advance Celerion's capabilities, reputation, and competitive position in the marketplace.
Requirements
- Ph.D. or M.Sc. degree in biochemistry, immunology, pharmacology, analytical sciences, molecular biology, biotechnology, or a related scientific discipline, with significant relevant industry experience in regulated bioanalysis supporting nonclinical studies and clinical trials.
- A minimum of approximately 12 years relevant industry experience, including progressive leadership responsibility and change management within ligand binding or large molecule bioanalysis.
- Deep scientific understanding and practical experience with ligand binding assay principles with strong experience with large molecule pharmacokinetic, biomarker and immunogenicity bioanalysis.
- Working knowledge of applicable regulatory expectations and industry guidance governing regulated bioanalysis, including relevant FDA, EMA, ICH, and GLP/GCP expectations.
- First-hand experience as a Study Director, Principal Investigator, Bioanalytical Project Manager or equivalent role supporting regulated studies within a GLP/GCP-compliant environment.
- Experience participating in or supporting sponsor audits and Health Authority regulatory inspections.
- Demonstrated experience managing, developing, and leading scientific teams, preferably within a growing or changing laboratory environment, with demonstrated ability to develop talent, manage performance, and foster collaboration and knowledge sharing.
- Demonstrated ability to translate business demand into staffing, equipment, technology, capacity, and financial plans.
- Strong client-facing skills with the ability to explain complex scientific and regulatory concepts clearly to both technical and non-technical audiences.
- Experience supporting proposals, scientific presentations, bid defenses, and business development activities.
- Knowledge of laboratory automation, data acquisition and analysis systems, electronic laboratory systems, and LIMS platforms such as Watson or equivalent systems.
- Experience utilizing scientific software, data analysis systems, statistical tools, and emerging digital technologies.
- Strong written and verbal communication skills and demonstrated ability to influence across functions and organizational levels.
- Demonstrated ability to manage multiple priorities, resolve complex scientific and operational problems, and make sound decisions in a fast-paced environment.
- A strong external scientific profile, including participation in professional organizations, scientific meetings, industry working groups, publications, or presentations, is preferred.