Job description:
1. Lead the Analytics Team to complete the analysis of high-end generic and new drugs for European, American, and Chinese markets, and establish new technology platforms.
2. Direct and audit standard operating procedures of all labs and improve the laboratory quality control system. Have English communication skills, proficiency in reviewing the reports and regulatory submission dossier.
3. Conduct the quality research and stability study of new and generic drugs, review experimental protocols for quality research and stability study, and lead the team to provide efficient and accurate support for the R&D of preparations.
4. Solve difficulties and problems encountered by the Analytics Team in the drug analysis process.
5. Guide and provide training to the Analytics Team, and establish training and career development plans for department personnel.
Qualification:
1、Pharmaceutical Analysis, Medicinal Chemistry or related majors. Hold a diploma in vocational education Master’s degree and 10 years of experience in related industry fields, or doctoral degree and 5 years of experience in related industry fields, Have experience in the development / verification / transfer of analytical methods of APIs or complex drug products, at least 3 years of experience in the management of R&D team.
2. Have proficiency in operating all analytical instruments; independently establish new drug specifications and analytical methods; conduct quality research, establish specifications, and draft documents for the application of new drugs; and be familiar with the application requirements stated in CFDA, FDA and EDQM, ICH guidelines and other relevant regulations.
3. Exhibit communication and organization skills, and work well in a team.
Pharmaceutical Analysis, Analytical Chemistry, Organic Chemistry or related majors. Hold a diploma in vocational education Master’s degree and above, at least 3 years of experience.
Have a passion for R&D work, a strong willingness to learn, a high ability to solve problems, a strong sense of responsibility, and a positive working attitude.
Possess sound teamwork consciousness, strong organization and coordination skills, conscientious, responsible, honest, and trustworthy attitude.
Have excellent English communication skills, proficiency in professional English for drug analysis, and the ability to read and translate relevant English literatures, and compile reports on experimental conclusions;
Analytical Scientist
Have proficiency in the use, maintenance, and upkeep of drug analysis instruments and related software;
Be familiar with all processes involved in the preparation R&D and drug analysis, the validation of analytical methods, and related regulations (including ICH, USP, EP, JP, and CP);
Senior /Scientist
Have proficiency in the development and validation of drug analysis methods; and related regulations (including ICH, USP, EP, JP, and CP);
Have the ability to quickly develop drug analytical methods based on compound structures and properties, and solve complicated issues that arise in the method development process;
Job description:
1. Responsible for the management of the R&D laboratory and drug development system of the company.
2. Formulate the department’s annual R&D plan, organize its implementation, control project progresses, and complete annual R&D tasks.
3. Undertake the project initiation, evaluation, design, R&D, and application of new products.
4. Prepare R&D project implementation plans, control key process nodes, evaluate technical bottlenecks, proposes solutions, and reduce project development risks;
5. Guide the resolution of significant technical challenges during the R&D process and the manufacturing transformation process;
6. Undertake the application of projects and the review of original records and CTD data;
7. Perform the daily management of the R&D lab and the cultivation and training of team personnel;
8. Initiate projects for target products, including monitoring original research or development status, assessing domestic and international market conditions, tracking patent situations, analyzing ongoing research, and providing preliminary analysis of project feasibility and reports.
Qualification:
(Depending on experience and interview results. expert training opportunities are available.)
1. Have 5-20 years of experience in pharmaceutical preparation. Ph.D. holders are preferred.
2. Have experience in the R&D, scale-up, and manufacturing of complex dosage forms, such as topical. microsphere or microneedle Experience in skin cosmetics development is also relevant.
3. Understand domestic accessibility of raw and auxiliary materials, comprehend regulatory requirements, and possess practical experience in complex preparation development processes, with experience in the successful application of approved products.
4. Have experience in the whole R&D process of semi-solid preparations and softgel is preferred.
5. Work well in a team, have good communication skills; show a willingness to grow, and be goal-oriented.
Job description:
1. Assists in/Undertakes the project initiation, evaluation, design, R&D, and application of new products.
2. Implement the department’s annual R&D plan, organize its implementation, control project progresses, and complete annual R&D tasks.
3. Prepare R&D project implementation plans, control key process nodes, evaluate technical bottlenecks, proposes solutions, and reduce project development risks.
4. Guide the resolution of significant technical challenges during the R&D process and the manufacturing transformation process;
5. Undertake the application of projects and the review of original records and CTD data;
6. Maintain the management of the R&D laboratory and drug development system of the company. and perform the daily management of the R&D lab and the cultivation and training of team personnel;
Qualification:
1.Hold a diploma in Bachelor’s degree and above, Pharmacy or related majors. 5 years of experience in pharmaceutical R&D with minimum 2 years of experience in management of R&D team,
2. Be familiar with the entire process of drug R&D and registration application and understand CDE/FDA technical review requirements.
3. Master formulation and process development and project application materials preparation;
4. Master manufacturing technologies, have proficiency knowledge in drug R&D, and have rich experience in drug dosage form R&D;
5. Possess good English reading and writing skills and be able to independently review and translate relevant literature;
6. Exhibit a strong sense of responsibility and possess good communication and team management skills.
Job description:
1. Hold a diploma in Bachelor’s degree and above, Pharmacy or related majors.
2. Be familiar with the R&D process of pharmaceutics, and have the ability to independently conduct literature reviews, operate related lab equipment and instruments, and support the development of prescriptions, manufacturing of scale-up batches, and related quality research;
3. Complete original laboratory records as required and support the sorting and writing of relevant information for product registration;
5. Possess good English reading and writing skills;
6. Possess a strong sense of responsibility, good communication skills, and strong work execution.
Job description:
1. Hold a diploma in Bachelor’s degree and above, Pharmacy, Chemistry, Biology, Materialogy or related majors.
2. At least 1 years of working experience, have clear R&D ideas, be familiar with the production processes, and related regulatory requirements related to manufacturing;
3. Have the ability to independently carry out formulation and process development technology transfer, scale-up batches, manufacturing of applied batches, and preparation of application documents;
4.Have experience in the R&D, scale-up, and manufacturing of complex dosage forms, such as topical microsphere, or microneedle. Experience in skin cosmetics development is also relevant.
5. Be familiar with CDE and FDA registration regulations. Prior experience in successful submission is preferred.
6. Have proficiency in English reading and writing and be capable of independently compiling relevant application materials.
7. Have a passion for R&D work, a strong willingness to learn, a high ability to solve problems, a strong sense of responsibility, and good communication skills.
Job description:
Pharmaceutical Analysis or related majors. Hold a diploma in vocational education and an associate degree or above.
Have a basic understanding of or proficiency in the use common drug analysis instruments and related software, and the capability to perform some analytical experiments.
Be familiar with all processes involved in preparation R&D and drug analysis, the validation of analytical methods, and related regulations (including ICH, USP, EP, JP, and CP);
Have a passion for R&D work, a strong willingness to learn, a high ability to solve problems, a strong sense of responsibility, and a positive working attitude;
Master professional English for drug analysis, and the ability to read relevant English literatures;