Talent recruitment
Oligonucleotide Project – Production
Date: 2023-04-26
Number of recruits：1 person
Job responsibilities：
- 1）Responsible for the construction and management of company rules and regulations, production site management, 6S management, production equipment management, production safety management, etc；
- 2）Coordinate the personnel management and various production activities of the production department;
- 3）Responsible for the production capacity analysis of the production line, ensuring the rationality of the production plan, and evaluating the resource allocation and production capacity of the manufacturing department;
- 4）Issue production plans and tasks, arrange and control the progress of production operations;
- 5）Track the production situation, product demand, production process, output value target, etc., and complete the production target on time;
- 6）Respond to production abnormalities in time, track problems in time, and make reasonable suggestions;
- 7）Participate in the action plan and implementation of improving production efficiency and product quality;
- 8）Monitor the standard operation methods, implement the company's 6S specifications, and ensure the safety and cleanliness of the production site;
- 9）Complete other tasks assigned by the leader.
Job requirements
- 1）Chemistry, applied chemistry, chemical engineering and technology and other related majors;
- 2）Relevant knowledge of solid phase synthesis is preferred, and relevant experience in nucleic acid synthesis and purification is preferred;
- 3）Excellent communication ability, affinity, with certain stress resistance and adaptability;
- 4）More than 2 years of GMP work experience in pharmaceutical factories is preferred.
QA (verification)
Date: 2023-04-07
Job responsibilities：
- 1）Participate in the establishment, operation and maintenance of the GMP quality system of new projects, ensure that the quality system can meet the requirements of GMP and have the ability to draft relevant quality system documents;
- 2）Manage collect, organize and archive the external materials that including but not limited to domestic and foreign regulations, equipment unpacking data, etc.
- 3）Participate in the equipment acceptance work in the construction stage of new project;
- 4）Participate in the verification of new project equipment, including the formulation of the master plan, the drafting and approval of the project, the implementation of the process and the drafting and approval of the report, etc;
- 5）Participate in the risk assessment of the project construction stage;
- 6）Participate in the deviations management of new project’s construction, including deviation investigation, drafting and approval of deviation reports, etc;
- 7） Participate in the CAPA management of new project’s construction process, including but not limited to formulation and tracking of CAPA measures;
- 8）Participate in quality audit and quality system evaluation to ensure the effective implementation of improvement measures;
- 9）Carry out the daily quality management of the enterprise, and review the methods for sample, test methods, various of documents and records;
- 10）Responsible for coordinating various audits and official on-site inspections, including participating in GMP inspections and dynamic on-site verification.
Job requirements：
- 1）Professional and responsible;
- 2）Have 2 years of GMP work experience in pharmaceutical factories.
QC (Drug Analyst)
Date: 2023-04-26
Job responsibilities：
- 1）Responsible for the daily management of the QC laboratory;
- 2）Formulate the relevant quality control systems and relevant implementation documents;
- 3）Collaborate with the method development team to complete the release of methodological validation for analysis method;
- 4）Cooperate with the team to complete the daily QC inspection (physical, chemical and microbiology), including but not limited to product release, stability, raw materials and package testing, water system testing, environmental monitoring;
- 5）Responsible for the drafting, revision, review and management of quality standards, SMP, SOP and other GMP documents related to release inspection;
- 6）Responsible for the daily management of QC-related instruments, reagents, standard products and inspection samples, etc;
- 7）Responsible for OOS/OOT, deviation investigation and analysis during the sample detection process;
- 8）Responsible for the summary of stability sample data, trend analysis, the review and archiving of inspection records;
- 9）Participate in the project meeting, communicate and solve relevant problems encountered in the project process;
- 10）Other related matters arranged by the superior.
Job requirements：
- 1）Master's degree or above in pharmacy, pharmaceutical analysis, analytical chemistry and other related majors with 2 work experience, and more than 4 years work experience for undergraduate;
- 2）Familiar with the regulations of FDA, ICH and the general analysis methods and guidelines of CHP, EP, JP, USP;
- 3）Physical and chemical: proficient in the use of conventional analytical instruments (HPLC, GC, UV, LC-MS/MS, ICP-MS, moisture meter, etc.);
- 4） Microorganism: proficient in the test of endotoxin, microbial limit and others;
BD Manager
Date: 2023-04-26
Job description：
- 1）Responsible for the market development of oligonucleotide CDMO business, and formulate market expansion goals according to the company's strategic deployment;
- 2）Engage in customer communication, including the regular conference call with customers, project progress email reports, etc. (Chinese/English), deal with technical and business negotiations of customers' products and production processes;
- 3）Familiar with the workflow of CDMO, responsible for coordinating the company's internal and external resources and business development, establishing the project implementation process;
- 4）Responsible for maintaining customer relations continuously, collecting customer feedback and market needs, feedback to the company timely, putting forward suggestions for improvement of service and delivery, and improving customer satisfaction continuously;
- 5）Assist in formulating relevant processes and norms for marketing, sales and customer business development, and training business-related personnel.
Job requirements：
- 1）Master's degree or above, biopharmaceuticals major, preference will be given to senior talents returning from abroad.
- 2）More than 5 years experience of sales/business development, CDMO business experience is preferred; experience in research and development, quality, project management, production or registration of biopharmaceutical enterprises is preferred;
- 3）Have good project management ability and be good at coordinating CDMO-related work between departments;
- 4）Excellent interpersonal communication, organizational coordination and business negotiation skills;
- 5）Have good English listening, speaking, reading and writing skills and good communication skills;
- 6）Have a strong sense of responsibility and dedication, and strong self-motivation.
Registration Manager
Date: 2023-04-26
Job description：
- 1）Responsible for docking CDMO holders to go on the registration preparation, approval, follow-up and coordination work, etc;
- 2）Responsible for writing/organizing the technical department to write Pre-IND, IND and BLA drug registration application materials, ensure the comprehensive, complete, true and reliable of drug application materials;
- 3）Provide customers with regulatory registration consulting services, assist customers to apply for Pre-IND communication meetings, etc.;
- 4）Develop a registration strategy for the project and provide professional registration guidance in the implementation of project;
- 5）Formulate or improve relevant departmental regulations and SOPs;
- 6）Collect and interpret business-related drug registration regulations;
- 7）Establish and maintain the relations with relevant departments of the Food and Drug Administration.
Job requirements：
- 1）Master's degree or above, pharmacy/biopharmaceutical and other related majors are preferred;
- 2）More than five years of work experience for drug registration in the pharmaceutical industry or professional background in process development/inspection in the biopharmaceutical industry;
- 3）Familiar with the drug registration process, familiar with the relevant laws and regulations requirements of drug registration, familiar with the drug registration workflow, and can be responsible for the whole process of project registration independently;
- 4）Strong communication, writing ability, and excellent organizational, coordination ability.
Total 5
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