Job
Description
e are seeking a highly motivated and experienced Lead Scientist Formulation & Development (Oncology) to lead formulation strategies and execution for our oncology portfolio. This critical role involves overseeing the development of safe, stable, and effective drug productsfrom discovery support to clinical trials and commercial readiness. The successful candidate will possess strong technical expertise in formulation science, a deep understanding of oncology therapeutics, and broad experience in managing CMC deliverables and cross-functional collaboration. Key Responsibilities Formulation Development Lead formulation and drug product development for small molecules, biologics, ADCs, or complex oncology compounds. Perform pre-formulation studies including physicochemical characterization, solubility profiling, and stability assessments. Design and optimize various dosage forms such as injectable (solutions, lyophilized powders, emulsions), and novel delivery systems (liposomes, nanoparticles, depot injectables). Select and justify excipient and formulation components based on biopharmaceutics, compatibility, and stability. Apply Quality by Design (QbD), DoE, and risk assessment strategies to formulation development. Process Development & Technology Transfer Develop scalable, robust manufacturing processes for clinical and commercial drug products. Author and review batch records, process descriptions, and technology transfer documents. Work closely with Process Development, Analytical Development, and Manufacturing teams to ensure seamless scale-up and tech transfer to GMP facilities or CDMOs. Conduct and troubleshoot scale-up and pilot manufacturing runs for clinical supply production. Analytical & Stability Support Define product specifications and critical quality attributes in collaboration with Analytical Development. Design and manage stability studies as per ICH guidelines to support shelf life and packaging decisions. Review analytical data and contribute to method development where necessary. Regulatory & CMC Documentation Serve as the formulation lead for CMC teams and contribute to global regulatory filings (e.g., IND, CTA, IMPD, NDA, BLA). Author and review key regulatory documents including Module 3 sections related to formulation, manufacturing process, stability, and controls. Respond to regulatory agency queries and provide technical justifications as needed. Project Leadership & Strategy Serve as subject matter expert (SME) and technical lead on cross-functional project teams. Collaborate with Discovery, Clinical, Regulatory, QA, and Supply Chain teams to align formulation strategies with clinical and commercial needs. Contribute to CMC strategy, timelines, risk management, and decision-making processes. Identify innovative formulation solutions to enhance bio availability, targeting, or patient compliance in oncology therapies. Vendor & Resource Management Manage relationships with CDMOs, CROs, and other external partners for formulation development and clinical supply manufacturing. Evaluate and select external vendors for formulation development, process optimization, and production. Monitor budgets, timelines, and performance metrics for outsourced activities. Team Leadership & Development Mentor and supervise junior scientists and associates, fostering scientific rigor and technical excellence. Contribute to recruitment, training, and career development of team members. Promote a culture of collaboration, innovation, and compliance within the team. Qualifications Required: Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical/Biomedical Engineering or related field with 10+ years of industry experience. Proven track record in formulation development of oncology therapeutics across multiple development phases. Deep understanding of biopharmaceutics, drug delivery systems, and formulation strategies for poorly soluble or unstable compounds. Strong knowledge of regulatory guidelines (FDA, EMA, ICH) and experience contributing to global submissions. Demonstrated leadership in cross-functional development teams and CMC activities. Preferred: Experience with complex modalities (e.g., liposomes, nanoparticles, ADCs, sustained-release). Familiarity with containment strategies for handling cytotoxic compounds. Experience working in or with CDMOs. Exposure to commercial scale-up and lifecycle management. Core Competencies Strategic thinking with strong problem-solving abilities. Excellent project management, communication, and organizational skills. Detail-oriented with a strong scientific and regulatory mindset. Team-oriented leader with ability to work in a matrix environment.
