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.
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Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 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 Executive Director of Active Pharmaceutical Ingredient (API) will be responsible for small molecule API Development for Structure Therapeutics’ CMC projects including design of alternative syntheses and development of reproducible, robust manufacturing processes under cGMP. This individual will support all drug substance activities in contract development and manufacturing organizations (CDMOs). All interactions with CROs or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.
Essential Duties and Responsibilities
1. Leads and manages multiple projects simultaneously, allocates resources and coordinates project activities to facilitate the achievements of major milestones of projects to ensure required deliveries on time.
2. Understands the strategy of API process development for early and late stages of projects.
3. Interacts efficiently and effectively with other line functions including Medchem, tox, and clinical operations to deliver projects in time with high quality.
4. Clearly understands the developmental issues of projects and develops strategies to resolve them.
5. Directs internal and CRO teams to perform experiments to define process parameters intended to develop suitable processes for chemical manufacturing and commercialization. Must apply organic chemistry, chemical engineering, safety, and green chemistry principles to design concise synthesis and experiments, optimize reactions, streamline workup procedures, and reduce cost and cycle time.
6. Manages all aspects of compliance issues (cGMP requirements and EHS regulations).
7. Clearly communicates project progress and needs, and interfaces with analytical, engineering, technical services, and process research groups to function as one team.
8. Mentors process chemists at CROs and CDMOs on a variety of subjects including process development, scale-up, regulations, and pilot plant/kilo lab equipment if needed.
9. Monitors the progress of projects and provides technical solutions to CRO and CDMO chemists to solve issues occurring during process development.
10. Proactively participates in team activities as an excellent team player, contributes to project deliverables.
11. Authors, reviews, and delivers technical documents for regulatory submissions and publications.
12. Ensures that CROs and CDMOs maintain compliance with cGMPs, cGLPs, FDA, ICH guidelines, SOPs, and NMPA regulations.
13. Oversees daily activities for drug substance development at CROs and CDMOs.
14. Provides managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance (For all Supervising Managers).
15. Other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
* PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Communication & Interpersonal Skills
* Language required: English and Chinese.
* Excellent verbal and written communication skills.
* Ability to effectively collaborate in a dynamic environment.
QUALIFICATIONS
* Ph.D. degree in Organic Chemistry, preferred in Organic Synthesis.
* 15+ years of working experience in API development in biotech/pharma industry or CROs. Being skilled in the application of GLP/cGMP is required.
* Extensive drug substance process development background and hands-on experience with working knowledge of cGMP manufacturing.
* Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
* Have both broad and in-depth knowledge as well as hands-on experience in modern organic chemistry techniques. Outstanding problem-solving abilities.
* Demonstrate knowledge of drug substance development, the ability to troubleshoot process development issues.
* Project management skills are required.
* Demonstrate a proven track record in working with and managing CROs and CDMOs for new synthesis design and execution in the lab and manufacturing.
* 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 the highest ethical standards.
* Excellent team player.
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