Recruitment Contact Information
Email: hr@bioinnobio.com
Telephone: (086) 0512-80606720; (086) 0512-80608677
Production and Operation
Purification Production Manager / Supervisor
Be responsible for workshop operation management, personnel training, performance management.
Be responsible for the reception of purification process technology transfer, implementation of large-scale production process conditions and quality improvement.
Be responsible for workshop purification management procedure document, operation procedure document, verification protocol, record, etc.
Be responsible for URS, FAT, SAT, IQ, OQ and validation of purification equipment.
Be responsible for the maintenance of purification equipment.
Be responsible for commissioning, and process scaling up.
Be responsible for achieving the tasks of purification production and summarizing batch production report.
Be responsible for the maintenance of the workshop environment.
Be responsible for the investigation of deviation and other quality incidents, implement corrective measures.
Purification Engineer
- Prepared purification workshop operation documents, verification schemes, records, etc.
- URS, FAT, SAT, IQ, OQ and validation of purification equipment.
- The maintenance of purification equipment.
- Commissioning, and process scaling up.
- Be responsible for the maintenance of the workshop environment.
Preparation Production Engineer
Participate in relevant experiments, pilot production and GMP production activities in the technology transfer process of sterile preparation project, be familiar with the operation of filling line and isolator, participate in preparation process production activities such as solution preparation, sterile filtration, sterile filling, capping, freeze-drying and visual inspection, be able to strictly follow GMP compliance requirements in the production process, have good GMP awareness and strong practical ability.
Be familiar with relevant requirements of GMP regulations, be able to independently draft validation documents and lead the implementation of validation, maintain the compliance of validation activities, and be responsible for but not limited to the validation of preparations, process validation, cleaning validation, aseptic process simulation validation, sterilization cabinet, isolator, filling line and lyophilizer (including IQ / OQ / PQ of production line equipment, smoke test, etc.).
Be familiar with sterile preparation quality system and relevant laws and regulations, be responsible for the writing of deviation, CAPA and change, and be able to lead and complete relevant investigation and evaluation.
Participate in the drafting of post SOP, batch records, process procedures, EHS and other relevant contents and ensure their strict implementation.
Carry out on-site work such as production operation, cleaning / disinfection / sterilization of plant / equipment / tools and instruments, daily maintenance / maintenance of production equipment / auxiliary facilities and 6S management in strict accordance with the SOP, batch records and process procedures of the post, and fill in records, identification and other relevant contents in a timely, accurate and truthful manner.
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Be responsible for workshop operation management, personnel training, performance management.
Be responsible for the reception of purification process technology transfer, implementation of large-scale production process conditions and quality improvement.
Be responsible for workshop purification management procedure document, operation procedure document, verification protocol, record, etc.
Be responsible for URS, FAT, SAT, IQ, OQ and validation of purification equipment.
Be responsible for the maintenance of purification equipment.
Be responsible for commissioning, and process scaling up.
Be responsible for achieving the tasks of purification production and summarizing batch production report.
Be responsible for the maintenance of the workshop environment.
Be responsible for the investigation of deviation and other quality incidents, implement corrective measures.
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According to the work arrangement of the supervisor, ensure to complete the experimental progress on time and independently and understand the work content;
Carry out cell culture and construction of genetically engineered cell lines;
Use various molecular biology techniques to construct genetic engineering vectors;
According to the needs of customers, design appropriate experimental scheme through Chinese and English literature review and communication with the supervisor;
Collect and sort out experimental data, be good at finding and solving problems encountered in the laboratory, and complete the writing of Chinese and English experimental reports;
Complete the writing of Chinese and English experimental record book in time and accurately;
Participate in the daily operation and maintenance of the laboratory and instrument management;
Research and Development
Biopharmaceutical R & D Director / Manager
Project Manager
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Cell Line Construction Assistant Researcher
Establish compliance department system documents, organize the implementation, supervise and inspect the operation of the quality system in the production process
Responsible for department coordination and organization of compliance, self-examination and audit management of the production department
Regularly provide targeted compliance-related training and communication
Participate in the formulation and maintenance of compliance inspections, identify high-risk compliance issues, and communicate with leaders regularly to improve the compliance status of the department
Carry out various inspections related to compliance, follow up the implementation of inspections, etc.
Responsible for the implementation of the quality management system of the production department, the implementation of GMP regulations and the implementation of the company's quality management documents
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Be responsible for the management of the company's projects, including McAb, ADC, CGT, analysis and detection, culture medium development and production, etc;
Be responsible for all aspects of fine management of the project, including contract review, project start-up, implementation plan, schedule management, cost control, revenue (payment collection) confirmation, key risk control, outsourcing management required for project implementation, etc;
Set up project members for the responsible project, start the project (including internal team start-up and customer start-up), and ensure that both parties reach an agreement on the service content, quality standard and timeline;
Formulate the implementation plan and payment collection plan for the responsible project, and track the project progress and revenue (payment collection) confirmation according to the plan;
Establish customer contact and customer relationship management for the project in charge. Regularly report the project progress to the customer and organize the customer project exchange meeting according to the contract or the customer's requirements;
Establish electronic archives of project information for the project in charge, and strictly implement standardization and confidentiality management, including contracts, meeting minutes, information provided by customers, process documents, project delivery documents, etc; Ensure the confidentiality management of customer information and project data;
Actively follow up the progress of the project, identify, monitor and respond to risks and anomalies in time, correctly evaluate the overall impact of corresponding risks and anomalies on the project, and organize project members to discuss reasonable countermeasures as needed;
During project implementation, control the project scope according to the contract requirements to ensure that the project implementation activities are within the scope of the contract;
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Compliance Supervisor / Manager
The role of the auditor is to conduct BioInno (hereinafter refer as BIB) external and internal quality compliance audits. The auditor's responsibilities include the performance of the audit projects accepted by BIB, the audits for BIB suppliers and the self-inspections of BIB quality system.
Validation Supervisor
The role of the validation supervisor is to maintain and implement validation management system, to ensure BioInno activities are in full compliance with Chinese, US and European requirements for cGMP and data integrity. This includes all manufacturing, engineering, Quality Control and Quality Assurance.
Quality Class
QA Supervisor
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Care for quality assurance functions. Support the quality system management, risk management, product quality planning and monitoring throughout the whole product lifecycle.
Defines, communicates, and gains cross functional and cross-site support for the quality system and compliance strategy to mitigate product and compliance risk.
Responsible for the company's quality related training management, including preparing annual training plan, tracking training performance, organizing annual training review.
Responsible for organizing the establishment, implementation and monitoring of the company's data integrity system.
Organize quality related document management and record management, issue batch production records and analytical records, and archive all quality related records.
Support company quality self-inspections, regulatory inspections and customer audits.
Participate in process/quality improvement projects.
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