Salary:20-35k · 15 salary
Experience requirements:3-5 years
Educational requirements:PhD
Job Description:
Job Purpose Job Objective
Overview of the purpose or role of the job and its value within the organization
This position is responsible for synthetic route design, scouting, and optimization of drug substance (API), registration starting material (RSM), and starting materials (SM). To timely develop a robust and cost competitive synthetic route for IND filing and clinical manufacturing is the key targeted deliverable from this position.
This position is responsible for designing, exploring, and optimizing synthetic routes for active pharmaceutical ingredients (APIs), registered starting materials (RSMs), and starting materials (SMs). The main goal of this position is to develop a robust and cost-effective synthetic route for IND application and clinical material production in a timely manner
Roles&Responsibilities Main Responsibilities
Lead and manage multiple route design & scouting, process R&D lab work, and production activities for early/late/commercial phase projects to ensure well resource/equipment planning, on-time delivery, and quality compliance, including goods, report, and HA filing package.
Lead and manage the laboratory work of route design, exploration, process development, and production activities for multiple early/late/commercial stage projects to ensure reasonable planning of resources/equipment plans, timely delivery, and quality compliance, including product, report, and health regulatory agency declaration related documents
Perform API/RSM/SM synthetic route/manufacture process design, scouting, optimization and related hands-on lab work, to support manufacturing activities for pre-clinical, clinical and commercial batches.
Carry out the design, exploration, and optimization of API/RSM/SM synthesis routes and production processes, as well as related laboratory work, to support preclinical, clinical, and commercial batch production activities
Manage the cooperation with CRO/CDMO to support the manufacturing of API/RSM/SM.
Responsible for collaborating with CRO/CDMO and supporting the scaling up production of API/RSM/SM in CRO/CDMO
Identify lab deficiency, timely organize team discussion, ultimately promote the continuous development and optimization of the lab. Ensure the efficient & safe running of synthetic lab to meet project needs.
Identify laboratory problems and areas for improvement, organize timely discussions, and ultimately promote the continuous construction and optimization of the laboratory to ensure efficient and safe operation of the synthesis laboratory and meet project requirements
Communicate with external function/team to ensure understanding project, including pre-CDID stage to commercial stage.
Communicate with external departments/teams to gain a deeper understanding of projects at various stages, including pre CDID projects to commercial projects
Take part in identifying and assessing risks/issues impacting project plan, and timely implement mitigation plan.
Participate in identifying and evaluating risks/issues that affect project plans, and implement mitigation measures in a timely manner
Prepare HA filing package, annual report, and various communication package per project needs.
Prepare official application materials, annual reports, and various communication meeting materials
Prepare the know-how management documents.
Participate in the preparation of management documents for proprietary technology
Maintain professional skills/knowledge by keeping abreast of literature, regulations, and guidelines.
Maintain professional skills/knowledge by reading literature, regulations, and guidelines
Proactively participates in team activities as a good team player, contributes to project deliveries.
As an excellent team member, actively participate in team activities and contribute to project delivery
Other related duties as assigned to meet company objectives.
Other related responsibilities assigned to achieve company goals
Job Requirement
A Ph.D. degree in organic or medicinal chemistry with >= 3 years of experience (including postdoctoral studies) in synthetic route design & scouting and process R&D in small molecule API (NCE) within pharmaceuticals, with exposure to late phase development is a plus.
A doctoral degree in organic or pharmaceutical chemistry with over 3 years of experience in designing, exploring, and developing synthetic routes for small molecule drugs (including postdoctoral research), with priority given to those with later project experience
A proven track record in developing cost-effective routes and process for API production is a must requirement.
It is necessary to have a good record in developing cost-effective production routes and processes for active pharmaceutical ingredients
Experienced in API process up-scaling and GMP pilot production.
Experience in API process scaling up and GMP pilot production
Knowledge of cGMP and EHS.
Have knowledge of cGMP and EHS