Key Responsibilities:
1.Technical Leadership:
（1）Provide technical leadership on formulation development, process scale-up, and fill-finish activities for oligonucleotide drug products.
（2）Troubleshoot and resolve technical issues related to drug product formulation and manufacturing.
2.Establish Drug Product Capabilities:
（1）Build and develop SanegeneBio’s internal oligonucleotide drug product (DP) development capabilities, including formulation, process development, and fill-finish capabilities to support pre-clinical studies.
（2）Develop and implement phase-appropriate formulations to support pre-clinical, clinical studies, and eventual commercialization.
3.Manage Drug Product Development and Fill-finish Activities:
（1）Lead and oversee all internal and external DP development activities, including formulation, and process scale-up.
（2）Ensure timely execution of DP development and fill-finish activities to meet pre-clinical and clinical study timelines.
（3）Evaluate CDMOs for drug product development and fill-finish operations.
（4）Ensure external manufacturing and fill-finish activities meet quality, regulatory, and timeline requirements.
4.Collaboration and Cross-Functional Alignment:
（1）Coordinate with cross-functional teams (R&D, CMC, Quality, Regulatory, Pre-clinical and Clinical) to ensure DP development and manufacturing activities align with overall project timelines.
（2）Serve as the primary liaison for drug product development efforts at CDMOs, ensuring seamless collaboration.
5.Regulatory and Documentation Support:
（1）Support the preparation of CMC sections of regulatory submissions.
（2）Ensure that all development and manufacturing documentation is complete, accurate, and compliant with internal SOPs and regulatory requirements.

Job Requirements：
1、PhD/MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
2、Minimum 5-8 years of experience in drug product development, with at least 4 years focused on oligonucleotide-based products.
3、Proven experience working with external CDMOs and managing outsourced drug product manufacturing, particularly in oligonucleotide formulations.
4、Experience with pre-clinical and clinical phase development for parenteral (injectable) formulations.
5、Strong knowledge of drug formulation, process development, and fill-finish operations, specifically for oligonucleotide drug products.
6、Familiarity with the regulatory requirements for GMP manufacturing, stability studies, and clinical trial material production.
7、Excellent project management skills with the ability to lead multiple complex projects simultaneously.
8、Strong problem-solving skills and attention to detail.
9、Excellent interpersonal and communication skills to effectively manage internal teams and external partners.
10、Experience working in a biotech or pharmaceutical environment is preferred.
11、Ability to thrive in a fast-paced, dynamic environment, building capabilities from the ground up.