临床前制剂（副）总监(J10108)

该职位来源于猎聘 职责描述： Position Summary The Lead Scientist, Preformulation & Discovery Support, provides scientific and technical leadership for preformulation and early pharmaceutical development activities supporting the company's discovery pipeline. The individual will lead a small team responsible for developing developability strategies and generating high-quality data that enable candidate selection, preclinical studies, IND-enabling development, and intellectual property protection. The position requires strong expertise in solid-state chemistry, physicochemical characterization, formulation sciences, and biopharmaceutics, together with demonstrated leadership, project management, and scientific communication skills. The successful candidate will work in a highly cross-functional environment involving medicinal chemistry, biology, DMPK, toxicology, analytical sciences, process chemistry, regulatory, and external CRO/CDMO partners. ________________________________________ Key Responsibilities Scientific Leadership

• Lead preformulation strategy for discovery and early development compounds.
• Design and oversee studies evaluating physicochemical properties relevant to Preclinical Candidate Selection and drug development.
• Lead solid-form selection activities, including: o Salt screening o Polymorph screening o Co-crystal screening (when appropriate) o Solvate/hydrate assessment o Amorphous form evaluation
• Evaluate developability risks and recommend mitigation strategies.
• Provide scientific guidance for candidate selection based on pharmaceutical properties. Formulation Development
• Lead formulation development for: o Discovery pharmacology studies o PK studies and data interpretation o Toxicology studies o Early efficacy studies
• Design formulations for challenging compounds with poor solubility, low permeability, or poor stability.
• Develop enabling formulations to support early in vivo studies.
• Recommend formulation strategies for first-in-human development. Data Interpretation
• Interpret physicochemical and biopharmaceutical data, including: o Solubility o Dissolution o pKa o LogP/LogD o Hygroscopicity o Chemical stability o Solid-state characterization
• Analyze and interpret PK data in collaboration with DMPK scientists to understand formulation impact on in vivo performance.
• Integrate formulation, analytical, and PK data to guide project decisions. Intellectual Property Support
• Generate scientific evidence supporting patent applications.
• Contribute to invention disclosures.
• Prepare technical reports supporting patent prosecution.
• Provide scientific opinions regarding solid-form and formulation intellectual property. Documentation
• Prepare high-quality technical reports (e.g. salt screen, polymorph screen, patent content prep) .
• Write study protocols and development reports.
• Maintain complete laboratory documentation consistent with company quality systems.
• Present scientific findings to project teams and senior management. Team Leadership
• Lead and mentor a small team of preformulation scientists.
• Set project priorities and allocate resources.
• Coach junior scientists in experimental design and scientific interpretation.
• Foster a culture of scientific excellence and continuous improvement. Cross-functional Collaboration
• Collaborate closely with: o Medicinal Chemistry o Process Chemistry o Analytical Development o DMPK o Toxicology o Clinical Pharmacology o Regulatory Affairs
• Manage activities performed at CROs and CDMOs.
• Review external study reports and ensure scientific quality. 任职要求： Education
• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Physical Pharmacy, Chemistry, Materials Science, or a related scientific discipline.
• Alternatively, an M.S. degree with substantial industrial experience may be considered. ________________________________________ Industrial Experience
• Ph.D. with ＞ 5 years of relevant pharmaceutical or biotechnology industry experience; or
• M.S. with ＞ 8 years of relevant industry experience.
• Demonstrated experience supporting multiple discovery and preclinical development programs.
• Previous experience leading small scientific teams is preferred. ________________________________________ Technical Expertise Demonstrated expertise in:
• Preformulation sciences
• Solid-state chemistry
• Salt selection
• Polymorphism
• Crystallization science
• Solubility enhancement
• Biopharmaceutics
• Early formulation development
• Animal formulations
• Pharmaceutical excipients
• Dissolution testing
• Physical characterization techniques (PXRD, DSC, TGA, DVS, FTIR, Raman microscopy)
• Particle size characterization
• Stability assessment
• Risk assessment for oral drug products Experience with enabling technologies such as amorphous solid dispersions, lipid-based formulations, cyclodextrin systems, nanosuspensions, and other solubility-enhancing approaches is desirable. ________________________________________ Leadership Competencies The successful candidate should demonstrate:
• Scientific leadership
• Strategic thinking
• Excellent problem-solving ability
• Strong project management skills
• Effective people leadership and mentoring
• Excellent written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced biotech environment
• Strong collaboration across multidisciplinary teams ________________________________________ Preferred Qualifications
• Experience supporting IND-enabling programs.
• Experience preparing CMC documentation for regulatory submissions.
• Knowledge of Quality by Design (QbD) principles.
• Familiarity with computational developability assessment.
• Experience managing CROs and external partnerships.
• Experience supporting patent strategy and freedom-to-operate assessments.
• Familiarity with ICH guidelines relevant to early pharmaceutical development. ________________________________________ Training Requirements Candidates should demonstrate formal or documented training in one or more of the following areas:
• Pharmaceutical development
• Solid-state characterization techniques
• Preformulation studies
• Biopharmaceutics
• Good Documentation Practices (GDP)
• Good Laboratory Practices (GLP), where applicable
• Data integrity principles (ALCOA+)
• Root cause analysis and scientific risk assessment
• Laboratory safety and chemical handling
• Project management methodologies
• Familiar with AI tools

Participation in continuing professional development through scientific conferences, workshops, or advanced technical training is expected. ________________________________________ Success Measures Success in this role will be demonstrated by:

• Delivery of robust preformulation packages supporting candidate selection.
• Successful identification of optimal salt or solid forms.
• Development of fit-for-purpose formulations for preclinical studies.
• Timely delivery of high-quality technical reports.
• Effective interpretation of formulation and PK data to influence project decisions.
• Strong support of patent filings and intellectual property strategy.
• Successful leadership and development of the preformulation team.
• Effective collaboration across discovery and development functions.