JOB SUMMERY：
(1) Overall DS project management through collaboration with CDMO partners and cooperating with research, quality and supply chain to ensure project moving forward smoothly to meet clinic and commercial requirement align with regulatory perspective.

(2) Technical expert for drug Substance (DS) development, manufacturing and technical transfer for both early phase and late phase projects;

(3) Solid State Development (SSD) and particle engineering to ensure appropriate DS physical property


MAJOR ACCOUNTABILITIES：
1. DS project management align with regulatory, clinic and commercial requirements. establishing project timeline and proactively execute the activities with risk control and
contingence plan to complete all tasks on-time.

2. Take full responsibility for drug substance development and manufacturing from PCC to commercial stage including (1) early phase DS development: synthesis route confirmation, polymorph study, process development; (2) late phase DS development: carry over impurity, mutagenetic impurity study, DOE / QRA study; (3) commercial manufacturing: PPQ, CPV and continuous improvement. Ensure on time DS delivery to meet clinical study and commercial supply requirement.

3. Multifunction collaboration and communication to support DS projects. Participate cross-functional project teams’ discussion.

4. Organizing and participating DS information collection for IND and NDA

5. Ensure complies with EHS requirements.

6. As a main DS responsible person to collaborate and manage CRO/CDMO to ensure projects executed align with plan.

7. Author technical reports, protocols, and participate in the authoring of CMC DS sections of the clinical trial applications (IND/IMPD/CTA) and/or marketing applications (NDA/MAA)

Experience：
Ph.D. with at least 3+ years in Chemistry or pharmacy
Master’s degree with at least 5+ years in Chemistry or pharmacy

Specific skills：
1.Strong knowledge on chemical and pharmaceutical development with experience to lead projects and collaborate CDMO independently.

2.Familiar with drug substances research, development and manufacturing. Exceptional knowledge on GMP/GLP compliance and familiar with related guidance on laws/regulations for China/US/EMA and ICH/WHO.

3.Familiar with overall DS project elements for both IND and NDA. Identify the key CMC activities to ensure on time submission.

4.Continuously invest time and effort to gain new skills and knowledge required to succeed in the work.

5.Show strong willingness to work closely with peers within and outside the team toward a common goal.

6.Sets a highly ambitious, clearly prioritized vision for the team; provide clear direction and define priorities for the team; listen to the different voices and win the commitment of team members.

7.Additional to Chinese, fluently communication and writing with English is required.