Primary Duties:
- Lead the development of projects at various stages, spanning from late-stage discovery to human proof of concept, involving collaborations with academic institutions and both domestic and international Contract Research Organizations (CROs).
- Provide strategic leadership and oversight for drug substance development initiatives, overseeing the entire development lifecycle from discovery through manufacturing.
- Lead a multidisciplinary team of scientists and researchers, fostering a collaborative and innovative environment to achieve key milestones and objectives.
- Set strategic direction for drug substance development programs, establishing clear goals, timelines, and resource allocation to ensure successful project execution.
- Drive innovation and optimization in synthetic routes, purification processes, and characterization methods for drug substances, ensuring scalability, quality, and efficiency.
- Collaborate closely with cross-functional teams including medicinal chemistry, analytical chemistry, formulation, and regulatory affairs to ensure seamless integration and progression of drug development projects.
- Oversee the generation and selection of stable cell lines with the appropriate expression characteristics and oversee the development of the Research Cell Bank and Master Cell Bank.
- Supervise the development of reliable and scalable processes for upstream and downstream activities, including the expression, harvesting, and purification of recombinant proteins and monoclonal antibodies.
- Actively manage development activities at Contract Development and Manufacturing Organizations (CDMOs) for preclinical and clinical projects, including the production of Good Laboratory Practice (GLP) tox batches and Good Manufacturing Practice (GMP) batches for clinical studies.
- Develop formulations for drug products that meet desired stability and biologic delivery criteria in alignment with the target product profile.
- Create and validate analytical methods that indicate product stability for testing and release purposes.
- Develop product specifications in accordance with regulatory standards.
- Contribute to the formulation of biologics Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and participate in the authoring and review of CMC sections for regulatory submissions and responses to regulatory inquiries.
- Act as the CMC representative on Product Development Teams, collaborating cross-functionally to ensure projects progress according to the established timeline and budget.
- Play a significant role in expanding the scientific project portfolio by conducting due diligence on biologics assets from academic and industry partners.
Qualifications:
- Candidate Requirements: A Ph.D. in Biological sciences or Biochemical Engineering with a minimum of 12 years of industry experience, or a B.S./M.S. with at least 15 years of experience.
- Demonstrated leadership abilities, including effective communication with various stakeholders, the capacity to build and sustain strong relationships internally and externally, the ability to make informed decisions in a timely manner, the skill to build high-performing teams, foster a collaborative and inclusive work environment, and think critically and strategically.
- Hands-on experience in process development and scaling up for clinical manufacturing, including adherence to current Good Manufacturing Practice (cGMP) standards.
- Profound knowledge of analytical techniques and control principles relevant to biologics development and manufacturing.
- Direct experience in effectively managing development activities at external Contract Research Organizations (CROs).
- Strong understanding of regulatory requirements, including those from the International Council for Harmonisation (ICH), the United States (US), and the European Union (EU).
- Direct experience in preparing and reviewing CMC documentation for regulatory submissions and addressing regulatory queries.
- Knowledge of protein and antibody delivery systems and formulations for various administration routes.
- While expertise in either upstream or downstream processing, analytical method development, or biologics formulation is expected, familiarity with the other disciplines is desirable.
- Experience in the development of other therapeutic modalities, such as small molecules, cell and gene therapy, or vaccines, is a valuable asset.
