Job Details

#x 9; Process Leadership: Lead end-to-end process development and supply chain strategy for small molecule and oligonucleotide drug substances, supporting clinical and eventual commercial launches. Regulatory Contribution: Author and review IND/ IMPD and other relevant regulatory documentation, effectively gathering and presenting scientific data for global regulatory submissions. External Partnership Management: Oversee productive collaborations with Contract Development and Manufacturing Organizations (CDM - Os), Contract Research Organizations (CROs), and key vendors to ensure consistent, compliant, and high-quality API supply. Operational Excellence: Initiate and implement process optimizations, resolve manufacturing challenges, and ensure cost, safety, quality, and sustainability targets are met or exceeded. Quality Collaboration: Work closely with Quality Assurance and cross-functional partners to drive SOP development, specification setting, and adherence to established quality ...Director, Manufacturing, Clinical Research, Leadership, Project Lead, Business Services, Staffing, Development