• Serves as expert in cell processing technology development for manufacture of cell therapies within a GMP manufacturing environment.
• Establishes project plans and timelines for process development, process technology transfer and GMP manufacturing start-up for multiple stem cell therapy development projects, and manage activities through to punctually achieving goals.
• Provides technical and GMP guidance to members of the teams across process development, manufacturing and validation disciplines.
• Represents manufacturing and clinical manufacturing functions for authoring, reviewing and approval of GMP documents.
• Represents process development and clinical manufacturing functions in cross-functional team forums.
• Authors and assembles CMC sections of regulatory filing including INDs and amendments and equivalent documents for filings.
• Leads project sub-teams and working groups.
• Degree in a biological science with a minimum of 7 years or more years of relevant experience in biologics development including cell therapy development: PhD (preferred) with 7 or more years of relevant experience; or a MS with 12 or more years of industrial experience, or BS with 16+ years of industrial experience.
• Fundamental knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.
• Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under GMP, validation, Quality Systems and regulatory requirements.
• Demonstrated in-depth skills in designing, executing and interpreting experiments.
• Experience authoring CMC sections of CMC regulatory documents.
• Responsible for designing and directing long-term and middle-term development of structure optimization related platform for CAR-T therapy.
• Analyze and interpret the data generated during discovery, early and/or full development.
• Responsible for timely and effective communication of data, strategy and results to the project teams.
• Co-author and prepare key preclinical and clinical, and regulatory documents, scientific manuscripts and patent application, including, but not limited to: study protocols, study reports, modeling reports, investigator brochures, IND/IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
• Be responsible for building, training and leading a team of research and development;
• Resolve technical problems encountered and propose innovative ideas and prepare proposals.
• PhD and/or MD, strong scientific background in immunology or oncology.
• Have antibody discovery and characterization experience.
• Could do virus vector design and optimization.
• He/she is familiar with in vivo animal study, could evaluate drug potency and safety.
• Extensive knowledge of cell biology and cancer biology, solid scientific publication.
• Pharmaceutical industry R&D work experience is an advantage.
• Proficiency in English a plus.
• Data mining of large scale multi-omics data, next-gen-sequencing data in particular.
• Integrating multi-omics data for drug discovery and biomarker development.
• Developing useful computational tools and new algorithms for biological re-search.
• Providing expert data-mining support to drug discovery and translational re-search.
• Working in a multi-disciplinary team with lab scientists and IT professionals to support drug discovery.
• PhD or MS in bioinformatics, computational
biology, mathematics, computer science or other related fields.
• Languages Business-level oral and written English.
• 5+ years of relevant post-graduate research experience in bioinformatics data analysis.
• Independent problem-solving capability in bioinformatics field.
• Excellent skills in statistical software like R.
• Excellent skills with programming languages such as Perl and Python.
• Working knowledge in statistics
• Strong communication and interpersonal skills.
• Responsible for development and evaluation process for all BD opportunities worldwide, including in-licensing, out-licensing, collaborations, distribution agreements.
• Responsible for structuring, negotiating and execution of partnerships.
• Establish and maintain excellent relationships with potential partners and key stakeholders.
• Represent companies various partnering and scientific conferences.
• Assist company leadership with data and insights to develop business.
• Minimum of 8 years of experience in biopharmaceuticals.
• PhD in biological or pharmaceutical sciences
• Exceptional interpersonal, oral and written communication skills in English and Chinese
• Strong presentation skills to deliver recommendations.
• Good understanding of global biologics
research, development, regulatory, manufacturing processes and commercialization
• Experience in business development, licensing, market and competitive analyses, including a broad understanding of the financial, commercial and legal dimensions that support the evaluation process.
• Expected to travel as required to meet business needs.
• Support lifecycle management of release methods by evaluating and proposing enhancements to the test methods.
• Support activities related to the transfer and validation of analytical methods from Clinical to Commercial QC, and commercial QC to external testing sites.
• Assist with deviation, investigation, CAPA and change control activities at EdiGene and contract labs, as needed.
• Support inspection readiness activities.
• Develop, revise and review SOPs, protocols and technical reports.
• Participate in generating training module and instruction led training material.
• Responsible for generating trending charts for monitoring method performance, product quality, invalid rate and/or stability.
• PhD with 5+ years or Master with 8+ years of experience in a GMP environment.
• Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, Real Time PCR, ELISA, Cell Viability measurement, etc.
• Experience in performing analytical method validation and supporting method transfer activities.
• Familiarity with FDA, ICH and GMP guidelines.
• Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls.
• Excellent skills in Microsoft Office, data analysis software, and other related applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Independently designs biological assays and method control strategies.
• Leads method attribute assessment and scoring to identify critical quality attributes (CQA) of the method and critical reagents/equipment.
• Develops bioassays to deliver results with appropriate precision and accuracy to meet manufacturing and QC release needs.
• Leads bioassay method routine testing to support the process sciences organization.
• Deep experience in flow cytometry including research grade (8+ colors) and regulated (CLIA/QC 4-6 colors).
• Manages timelines for the method lifecycle including development, qualification and transfer to QC, QC validation, transfer to CTO if required, method changes or remediation, deviations, CAPA.
• Assesses bioassay method performance in analytical development and reviews method performance in QC. Identifies issues and remediates based on company priorities.
• Leads bioassay comparability testing supporting process changes and process transfers.
• Implements appropriate assay controls, and characterizes references standards in bioassays as required, aligned with the product attributes.
• Authors and reviews bioassay method development reports, drafts bioassay qualification protocols, mentors analytical and QC staff during co-qualification and reviews qualification reports, drafts bioassay validation protocols, supports QC during validation and reviews validation reports.
• Leads bioassay method transfer.
• Authors/reviews analytical method development, qualification, transfer, and method validation sections and supports Response to Questions (RTQ).
• Supports annual product reviews related to bioassay performance.
• Trends bioassay method performance in analytical development and supports method trending review in QC.
• PhD in cell biology, immunology or related fields, with 4-8 years of industrial experience, or MS with 8+ years of industrial experience.
• Fundamental knowledge of cell culture and immunology.
• Experience developing, transferring or validating analytical methods into regulated environments (e.g. QC labs).
• Experience with Stem cell manipulations.
• Demonstrated skills in designing, executing and interpreting experiments.
• Demonstrated skills and experience in Design of Experiments and statistical data modeling.
l Responsible for the construction and maintenance of the company's intellectual property legal protection system;
l Responsible for drafting, reviewing, modifying and complying with various external contract projects of the company;
l Provide legal support and compliance recommendations for the company's business management activities, and develop and improve the company's risk assessment and management system;
l Participate in the negotiation of company contracts and the review and review of legal documents, and organize the preparation of relevant contract texts;
l Assist all departments of the company to handle and resolve various legal disputes arising in the operation and safeguard the legitimate rights and interests of the company;
l Responsible for the company's litigation and arbitration activities, review and track the litigation cases handled by the company's entrusted legal service agencies, and put forward handling opinions to protect the company's legitimate rights and interests.
l Be the primary contact with the legal advisory companies supporting the Company.
l experience with international contracting strongly preferred.
l Bachelor degree or above, major in law; JD is preferred;
l Have the ability to undertake work tasks independently;
l Strong legal professional knowledge; rich experience in legal management and dispute handling;
l More than 5 years of experience in law or law firm, medical industry experience is preferred;
l Proficient in contract law, company law, e-commerce, intellectual property law, labor laws and regulations, etc.;
l Pass the national judicial examination and have a lawyer qualification certificate.
l 1. Responsible for the company's information system development plan, step-by-step development and use of application management software, and gradually realize enterprise management information.
l 2. Assist the marketing department in the company's website design and overall planning, responsible for the company's website construction and maintenance.
l 5. Responsible for managing and upgrading the company's network and communication system, responsible for informatization construction, including LAN interworking between headquarters and branch offices, virtualization platform construction, domain-based IT strategy implementation.
l 6. Network skills training and technical support for other departments of the company.
l Be the primary contact with IT consultants engaged by the Company.
l Bachelor degree or above in computer related major;
l More than 5 years of relevant IT department management experience;
l Understand and have the overall development and construction capabilities of the website, have good experience in implementing Lims system projects, experience in OA development and construction, and experience in MES system development and maintenance.
l Understand computer system structure and software and hardware management, server operating system management and computer network management technology.
l Strong communication and execution skills.
l Familiar with Java, PHP, ASP.Net and other development languages, at least one of them;
l Analyze human resource requirements based on existing compilation and business development strategies, and develop recruitment plans and recruitment budgets.
l Establish and improve the recruitment system, process and recruitment system of the unit.
l Develop, maintain, evaluate, and analyze various recruitment channels, including headhunting, campus, and forums.
l 4, resume screening, interview, screening, recruitment communication, tracking management and other work.
l Establish an enterprise talent pool, conduct statistical analysis on recruitment related data, and complete human resource data reports on a regular basis.
l 1. Bachelor degree or above, human resources and other related majors;
l 2, familiar with the recruitment process, skilled use of various recruitment tools and means;
l 3. Have rich recruitment experience and skills, and be familiar with relevant national laws and regulations;
l 4. Have good professional ethics and professional ethics and good sense of teamwork;
l 5. Excellent language expression and communication skills.
l 6. Experience in the biological and pharmaceutical industries is preferred.
l 1. Responsible for establishing and improving the company's internal control system, organizing identification and assessment of possible risks of the company, organizing various departments of the company to identify risks, and formulating risk response measures to track the effects of rectification.
l 2. Carry out financial management and accounting work according to the requirements of listed companies to ensure that the company's financial work is in line with the conditions for listing.
l 3. Responsible for organizing the company's financial accounting work to ensure that the company's financial accounting work accurately, timely and completely reflects the company's actual operating results and financial status.
l 4. Responsible for establishing an asset operation efficiency indicator system to monitor and improve asset operation efficiency.
l 5. Implement the company's budget management work, continuously optimize and improve the budget management system according to the actual situation of the company, formulate and improve the company's budget management measures and implementation rules, organize relevant departments to carry out budget promotion work, analyze the budget regularly, strengthen management and promote The realization of various economic indicators;
l 6, presided over the nuclear price management work and product pricing work, the development of product quota cost accounting standards and product pricing management system to ensure the realization of the company's established profits.
l 1. 35 years old - 45 years old, bachelor degree or above, major in accounting or financial management;
l 2. More than ten years of financial work experience in production enterprises, more than five years of financial management experience;
l 3. Proficient in business Accounting standards, experience in internal control management of listed companies;
l 4, strong organizational leadership, execution, communication and coordination;
l 5, familiar with financial regulations and tax laws, and financial management experience of listed companies.
l Responsible for procuring raw materials and accessories compliant with GMP regulation, and managing clinical supply chain to support the clinical trials.
l Assist in the development of production demand plans and update them in a timely manner.
l Forecast various related plans (people, machines, materials, sites, time, and costs) in the next 24 months, and coordinate the development of treatment programs. Coordinate production, procurement, logistics, QC, QA and engineering related resources with the goal of production planning to achieve the established production targets.
l Maintain smooth communication channels with relevant departments, and “site, current, and existing materials” follow up and feedback production progress.
l Maintain smooth communication with logistics, production, QC and QA, timely acquire, provide and feedback product logistics information, and follow the established process of single blood/finished product return SOP to ensure accurate integration of logistics links.
l Collect and maintain the master data related to material management and production planning management, and propose reasonable improvement suggestions based on actual operation.
l Full-time undergraduate degree or above.
l More than three years of work experience in supply chain or logistics, medical or biopharmaceutical related background, familiar with GMP, and GCP and better responsible for planning management in large pharmaceutical companies.
l Strong verbal and written communication skills, good analytical skills and coordination skills.
l Skilled in using Excel, Word, PowerPoint, SAP experience is better.
l English level 6 and above, with good listening, speaking, reading and writing skills.
l 1. Responsible for the construction management of the company's engineering projects to ensure the smooth completion of the project.
l 2, responsible for the management of other affairs of the department
l More than 5 years of working experience in the same position, working in biology, GMP workshop and pharmaceutical industry for more than three years;
l Familiar with HVAC system, water system, circulating cooling water, chilled water system, air conditioning self-control programming, relevant electrical and HVAC experience, and experience in pharmaceutical plants are preferred;
l Hydropower and construction related majors, with expertise in hydropower and construction;
l Good coordination and communication skills and keen information acquisition ability;
l Strong sense of responsibility, strong principle, strong organization and management ability;
Provide general secretarial services to CEO;
To assist CEO manage the internal project related to R&D, Business and Operations;
To assist CEO manage and expand external resource of investing, marketing, academic and scientific R&D;
To manage CEO's agenda and related information and document;
To coordinate CEO's travel needs including itinerary for domestic and international travel;
To assist CEO manage Internal communication and events;
To assist CEO arrange and manage other supporting activities as assigned.
Master degree or above, related in business administration/management preferred;
Over 5 years working experience as secretary or assistant to senior management, PR experience is a plus;
Proficient in English (written and Oral), overseas education or working experience is a plus;
Good interface with people, willing and capable to learn;
Experience in the biological and pharmaceutical industries is preferred;
Microsoft Office skills, including Word, Excel and PowerPoint.
Building No.22, Kexueyuan Road, Changping Distriction, Beijing, China
Building 10, No.6, Nanjianger Road, Zhujiang Street, Nansha Distriction, Guangzhou, China
245 FIRST STREET, RIVERVIEW II, 18TH FLOORCAMBRIDGE, MA 02142 USA