Associate Director, API at Structure Therapeutics

Pudong, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

05 Aug, 26

Salary

0.0

Posted On

07 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

API Development, cGMP, CRO/CDMO Management, Synthetic Route Design, Process Chemistry, Regulatory Filings, Project Management, Organic Chemistry, IND/NDA Requirements, Chemical Engineering, Green Chemistry, CMC Regulations

Industry

Biotechnology Research

Description

About Us: Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Position Summary The Associate Director of Active Pharmaceutical Ingredient (API) will be responsible for small molecule API Development for Structure Therapeutics’ CMC projects including design of alternative syntheses, development of reproducible, robust manufacturing processes under cGMP. This individual will manage drug substance activities in contract development and manufacturing organizations (CDMOs) to ensure delivery of high-quality results and reports in time to meet regulatory requirements. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings. KEY RESPONSIBILITIES Lead CRO/CDMO teams to reduce the cost of goods and shortening process development timelines through redesigning practical and efficient synthetic routes for scalable production. Direct CRO/CDMO teams to perform experiments to define process parameters intended to develop suitable processes for chemical manufacturing. Mentor process chemists at CROs and CDMOs on variety of subjects including CMC regulations, chemical engineering, safety and green chemistry principles to facilitate process development. Oversee daily activities for drug substance development at CROs and CDMOs, and monitor the progress of projects and provide technical solutions to CRO and CDMO chemists to solve chemistry and process issues & challenges, Manage multiple projects simultaneously, coordinate project activities to facilitate the achievements of major milestones of projects to ensure the deliverables on time. Clearly understands the developmental issues of projects and develops strategies to resolve them. Interact efficiently and effectively with other line functions including Medchem, formulation, Supply chain, QA, Tox and Clinical operation to deliver projects in time with high quality. Clearly communicate project progress and needs, and interfaces with analytical, formulation, supply chain and QA to function as one CMC team. Proactively participate in team activities as an excellent team player, contributes to project deliverables. Author, review, and deliver technical documents for regulatory submissions and publications. QUALIFICATIONS Ph. D. or Master degree in Organic Chemistry. 8+ years of working experience in API development in biotech/pharma industry or CROs. Being skilled in the application of cGMP is required. Demonstrate a proven track record in working with and managing CROs and CDMOs for synthetic route design and execution in manufacturing. Demonstrate knowledge of drug substance development from early phase to late phase, and the ability to troubleshoot process development issues. Have both broad and in-depth knowledge as well as hands-on experience in modern process chemistry techniques, IND/NDA regulatory requirement. Detail-oriented. Ability to critically evaluate and correctly interpret analytical data to solve problems. Multi-project management ability is required. Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and ethical standards. Excellent team player. Language required: English and Chinese

Responsibilities

Lead the development of small molecule API and robust manufacturing processes under cGMP. Manage CRO/CDMO teams to optimize synthetic routes, reduce costs, and deliver technical documentation for regulatory filings.