Director, Analytical Biochemistry & In vitro Assays

Position Overview:

The incumbent will lead a team and provide high level expertise and leadership capacity in Analytical Biochemistry and In vitro assays in support of drug discovery efforts using novel modalities within and external to CSL R&D. This role sits at the interface of discovery research, translational sciences, DMPK, toxicology, clinical pharmacology, CMC and regulatory functions. It requires scientific expertise with multiple modalities across Research and Development, proven experience working with and managing external academic and industry partners, and leadership skills to drive innovation and ensure the successful discovery and progression of drug candidates.

Work Environment:

*** This is a hybrid position based in Waltham, MA with a minimum of 3 days onsite required on a weekly basis.  Relocation and mobility assistance are not provided.

Key Responsibilities:

• Leadership and development of a team of Sr/Scientists, fostering innovation and excellence, development and execution of bioanalytical strategies that support discovery, preclinical and early clinical development programs

• Support the selection of appropriate therapeutic modalities, most importantly DNA and RNA-based therapies, potentially peptides and vaccines for specific disease targets

• Lead and participate in external due diligence and provide expert advice on modality suitability and risks

• Contribute to the Drug Discovery Leadership Team, driving CSL’s drug discovery efforts

• Foster a collaborative and high-performance culture within the team, encouraging innovation and continuous learning

Leadership and Management:

• Provide strategic direction for research projects, ensuring alignment with overall company goals and objectives

• Define the bioanalytical strategy across a portfolio of programs, build assays that generate critical efficacy, target engagement, biomarker and immunogenicity data

• Facilitate effective communication and collaboration among team members and across departments

• Manage team resources, including budget, personnel, and equipment, to optimize productivity and efficiency

• Lead and manage internal research activities and manage external projects, including performing wet lab due diligence activities, ensuring necessary resources and expertise

• Lead and manage research and lifecycle management activities for RNA-based vaccines

Scientific Excellence:

• Oversee the development, optimization, and validation of novel analytical methods and in vitro assays

• Ensure data generation is robust, reproducible, and meets regulatory standards and guidelines

• Foster collaboration with cross-functional teams to integrate assay data into broader research programs, contribute to the advancement of therapeutic candidates from discovery through to clinical development

Innovation and Development

• Identify and evaluate emerging technologies, methodologies, and best practices to enhance analytical capabilities and assay performance

• Drive continuous improvement initiatives, implementing new techniques and technologies to keep the team at the forefront of the field

• Contribute to the scientific community through publications in peer-reviewed journals, presentations at conferences, and participation in professional organizations

Project Management:

• Plan, execute, and monitor research projects, ensuring efficient use of resources and timely delivery of project milestones and deliverables

• Develop detailed project plans, including objectives, timelines, and risk management strategies

• Communicate project progress, challenges, and outcomes to stakeholders, senior management, and external partners

• Ensure compliance with all relevant regulations, guidelines, and quality standards throughout the project lifecycle

Minimum Qualifications:

• Postgraduate degree (preferably PhD). in Molecular Biology, Biochemistry, and/or extensive experience in relevant industry or academic environment – scientific and people leadership

• 10+ years of experience in analytical biochemistry and in vitro assay development, with a proven track record of successful research and development projects

• Prior experience in a leadership role is essential

• Experience with novel modalities such as gene therapy, peptides, cell therapy, or RNA-based therapeutics and vaccines

• Strong expertise in analytical method development, validation, and regulatory requirements