Job Title: Director of In Vivo Bioassay DevelopmentJob Description The Director of In Vivo Bioassay Development provides scientific, technical, and operational leadership for the development, qualification, and validation of in vivo and biological assays. This role ensures alignment with global pharmacopeia standards, drives continuous improvement, and supports site-wide initiatives through cross-functional collaboration. The Director is accountable for strategy, people development, and delivering scientifically sound, regulatory-aligned bioassay results that support global product quality and release. Responsibilities + Interpret bioassay statistics using parallel line models and non-linear regression to define dose-response relationships. + Design and manage assay protocols using Excel and statistical software, authoring validation documentation. + Review and trend assay performance to ensure data integrity and consistency. + Ensure fitness-for-purpose of methods used for lot release and stability, identifying areas for optimization. + Maintain and update computer programs for statistical evaluation of assay data. + Provide expertise in dose range selection and trending. + Coach and develop a multidisciplinary team of scientists, technicians, and animal care staff. + Set goals, provide regular feedback, and manage performance and development plans. + Foster a culture of scientific rigor, compliance, and ethical animal care. + Champion cross-training and succession planning within the team. + Ensure readiness and responsiveness to business and regulatory needs. + Ensure adherence to regulatory requirements and global animal welfare standards. + Oversee facility operations for bioassay and animal husbandry, ensuring GxP compliance. + Lead and support regulatory inspections and internal/external audits. + Implement and improve SOPs, risk assessments, and CAPA responses for inspection readiness. + Oversee accurate documentation of animal use and support Global Bioassay Ethics Committee submissions. + Align bioassay and animal care strategies with site and global business priorities. + Collaborate with QA, Regulatory Affairs, and R&D for method lifecycle management. + Recommend prioritization of projects and resources based on scientific complexity and business impact. + Participate in site leadership forums and global scientific councils to influence direction. Essential Skills + Bachelor’s degree in Biology, Pharmacology, Animal Science, or related field required; MS/PhD preferred. + Minimum 7–10 years of experience in in vivo scientific or regulated pharmaceutical environments. + Proven expertise in bioassay development, statistical modeling, and pharmacopeial standards. + Demonstrated success in leading high-performing scientific teams in a regulated environment. + Proficiency in Excel, GraphPad Prism, or other statistical software tools used for assay modeling. + Strong communication skills with the ability to influence across levels and functions. Additional Skills & Qualifications + Work in laboratory and vivarium settings, including exposure to animals and biological materials. + May involve standing for extended periods and lifting up to 30 lbs. Work Environment The role involves working in a GMP lab with occasional travel (up to 10%) required for audits, training, or collaboration with global teams. The work environment includes exposure to animals and biological materials, and may require standing for extended periods and lifting up to 30 lbs. Pay and Benefits The pay range for this position is $150000.00 - $160000.00/yr. Will be getting this week and adding Workplace Type This is a fully onsite position in Summit,NJ. Application Deadline This position is anticipated to close on Aug 27, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.