Applied Pharmaceutical Science
Achievement Passion Sincere
1. According to the Company's overall planning, formulate annual deployment on business development, develop cooperation resources, draw up plans and strategies for the introduction of new projects, seek and introduce products, and analyze product feasibility;
2. Search for potential opportunities of businesses cooperation and development, conduct market analysis and screening, organize internal project approval, and formulate business negotiation programs;
3. Contact and negotiate with target customers, deal with barriers in the cooperation to facilitate contract signing, and ensure that products and projects under responsibility are advanced and completed on time;
4. Conduct business negotiations and teleconferences with potential customers at home and abroad to communicate issues regarding product development plans and product registration;
5. Follow up the continuous promotion of cooperation projects, coordinate and solve problems emerging in project promotion, and boost project progress.
1. Bachelor degree or above, majoring in Business, Marketing, Biochemistry, Pharmacy or Clinical Medicine;
2. More than ten years of experience in business development in the medical industry, more than five years of management experience in similar position, and a deep understanding of the work content in this field;
3. Excellent public speaking skills, communication and coordination skills, organization and planning skills, and crisis public relations handling skills;
4. Rigorous logical thinking and analytical judgment, keen market insight, and strong sense of risk control;
5. Familiarity with regulations concerning new pharmaceutical preparations, raw material registration, etc.;
6. In-depth understanding of the biopharmaceutical industry (those with the background of business development in this field are preferred);
7. Proficiency in English as a working language.
1. Responsible for searching, collecting, and organizing literature and materials related to new drug projects;
2. Independently design target molecule synthesis routes to solve various chemical synthesis problems; timely complete the organization and archiving of experimental records and related materials;
3. Responsible for the synthesis, separation, and purification of target compounds, and the analysis and identification of compound structures; submit target compounds on time;
4. Participate in the design of compounds and analyze structural activity data; regularly submit stage achievement reports and work plans for the next stage.
5. Responsible for the management of the pharmaceutical synthesis department, including assessment of subordinates, development of relevant SOPs, and personnel training and team building within the department.
1. Master's degree or above in organic chemistry, pharmaceutical chemistry, or related fields; more than 5 years of experience in new drug research and development and team management; priority given to Doctoral degree;
2. Having theoretical knowledge related to organic synthesis, good hands-on experimental skills, and the ability to independently solve chemical synthesis problems;
3. Proficient in mastering the basic skills of organic chemistry, familiar with computer-aided drug design methods, willing to learn knowledge in the fields of pharmaceutical chemistry and new drug development;
4. Honest and trustworthy, with a spirit of teamwork; Good communication and organizational skills.
1. Combined with the company's strategy, formulate research directions and development strategies for innovative drug formulations;
2. Combined with the research and development direction of the company, establish an innovative drug formulation research and development platform;
3. Responsible for outsourcing technology and quality control of innovative drug formulation projects, including determining formulation research protocols, tracking research progress, regularly reviewing milestone reports, and ensuring that research work is authentic, scientific, and compliant; determining production and process validation protocols, reviewing and confirming batch records, process procedures, validation protocols, quality standards, and other documents;
4.Responsible for the outsourcing projects of the company and cooperating and communicating with CDMO, controlling key milestones, overseeing the progress of formulation research and production, and collaborating with the CMC team to oversee the overall project progress;
5. Responsible for writing, organizing, and reviewing IND, NDA, DSUR, supplementary applications, communication and exchange meetings, and other application materials related to formulations;
6. Responsible for screening formulation suppliers, assisting QA in completing compliance audits and related technical support for the CDMO service supplier;
7. Responsible for on-site verification of formulation registration.
1. Major in pharmaceutical preparations or related fields, with a bachelor's or master's degree or above, more than 3 years of experience in chemical drug formulation research and development, and independently completed more than 1 formulation research and development project;
2. Familiar with the research work of small-scale, pilot-scale, and large-scale production formulation processes; familiar with formulation equipment; can solve practical problems in formulation technology research and production;
3. Good ability to search and analyze literature in both Chinese and English, familiar with the requirements of national technical evaluation and relevant regulations of national drug management;
4. Strong sense of work responsibility, good team spirit and professional ethics;
5. Priority for those with experience in developing Class 1 innovative drug formulations.
1.Responsible for the construction of the siRNA drug delivery platform, supporting preclinical and clinical research and development of siRNA drugs;
2.Proficient in mastering and applying mature siRNA delivery technologies such as LNP and GalNac, and efficiently applying them to research and development projects;
3.Further improve and form patent achievements for mainstream delivery technologies such as LNP and GalNac, which are currently mature;
4.Explore new methods for delivering siRNA drugs and effectively apply them in drug development projects;
5.Exploring new delivery technologies targeting the liver and extrahepatic tissues to effectively deliver siRNA drugs to disease-related target lesions;
6.Explore siRNA drug delivery methods suitable for tumors and tumor immune indications, and produce results;
7.Establish and lead a siRNA drug delivery team to efficiently promote preclinical projects;
8.Collaborate closely with other functional departments of the siRNA team to conduct in vitro and in vivo research and provide support for the project's entry into clinical practice;
9.Familiarize and continuously follow up on the latest developments in siRNA drug development and related delivery technologies internationally, and design differentiated siRNA drug delivery research and development strategies and technology platforms within the company;
10.Responsible for departmental budgeting and efficient execution;
11.Effectively communicate with other departments and other research and development centers within the company, work closely together, integrate resources, and efficiently promote projects;
12.Participate or be responsible for evaluating and collaborating with external academic institutions or biotechnology companies on drug delivery technology according to company needs.
1.PhD degree in pharmaceutical chemistry, chemical engineering, and related fields;
2.More than 7 years of work experience in a biopharmaceutical company and more than 3 years of relevant work experience in siRNA drug delivery;
3.Experience in building and leading research and development teams;
4.Familiar with the overall process and policies and regulations of nucleic acid drug development, and led the research and development work of siRNA drug delivery projects as the main responsible person;
5.Rigorous scientific research thinking, strong execution ability, and strong ability to discover and quickly solve technical problems;
6.Priority for those with relevant work experience in overseas biopharmaceutical companies;
7.High sense of responsibility and self-drive, diligent and responsible in work with a positive attitude, and possessing team spirit;
8.Excellent verbal and written communication skills, with excellent English proficiency.
1. Based on project progress, formulate annual CMC goals and plans for the project, coordinate multiple departments, including analysis, synthesis, quality assurance, administration, finance, and clinical departments to ensure the smooth progress of the project;
2. CMC R&D management: Supervise the entire process of CMC in R&D projects, control key project milestones, supervise project progress, track work progress of project milestones, timely identify and coordinate problem-solving; organize various special meetings related to research and development, and supervise the implementation of various meeting tasks to be conducted;
3. Coordination and management: Externally, participate in the selection of outsourcing suppliers during the research and development process, and coordinate and communicate with relevant departments and units of outsourced research/production units (external coordination work is led by department heads); internally, conduct necessary coordination work with various departments of the company (Clinical Department, Biopharmacology Department, Analysis Department, Chemical Synthesis Department, Quality Assurance Department, etc;
4. Technical materials review: According to regulatory requirements, review technical documents generated during the research and development process, including process technology packages, quality standards, technical solutions, and technical reports, etc., review registration application materials, including IND, NDA, supplementary applications, and DSUR, and pay attention to the scientificity, rationality, and integrity of registration application materials;
5. Technical materials management: Manage various paper and electronic documents such as records, graphs, application materials, red-headed documents, and approvals generated during the project development process; manage the archiving, borrowing, and handover of original materials; establish and update various information and ledgers of related information for project research and development; manage project technical contracts;
6. Budget management: Based on project progress, develop annual CMC and registered project budgets, manage and control actual expenses incurred, and ensure that the project is completed on time within the budget range;
7. Assist department heads in preparing a complete set of registration materials and submitting drug registration materials to CDE or FDA; track the progress of drug registration and communicate and coordinate with CDE or FDA during the registration process;
8. Collect and organize laws, regulations, and registration requirements related to business in various countries, and communicate relevant regulations to relevant departments and personnel;
9. Timely and effectively complete other tasks assigned by the leader.
1. Bachelor's degree or above, major in pharmacy or related fields, master's degree is preferred;
2. More than 2 years of experience in pharmaceutical research and development project management. Priority for those with experience in research and development project management and registration;
3. Familiar with the new drug development process and relevant policies and regulations related to new drug research; have a good project management mindset, managing the entire project process and grasping key milestones;
4. Strong organizational, communication, and coordination skills; excellent professional ethics, professional competence, and teamwork ability.
Address
Office: San Diego,US
Office: Building 10-1, No.2 Jingyuan North Street, BDA, Beijing, China
Tel
+86-10-67860673