At Henlix, we strongly focus on talent development. We believe that the skills and leadership ability of our employees are the most important and precious resources of our company. The company is committed to talent recruitment and retention and to support the professional development of our employees. We strive to provide our employees the support and resources to learn, grow and achieve success.

Our company seeks to hire, retain and promote the best people. We strongly encourage our employees to take the initiative, to be creative and pragmatic. Our company culture encourages creative thinking and proactive problem-solving and values relentless pursuit of excellence. We strive to create the best work environment and are committed to help our employees develop their talents and career.

We welcome you to join Henlix and to grow with us.

  • 人數:1
  • 上班地點:Taipei
  • 職務內容
    1. Responsible for antibody drug purification, analysis and formulation.
    2. Small-scale process development of antibody purification and characterization.
  • 需要條件
    1. Strong background in protein purification and instrumentation (AKTA system).
    2. Strong background in analytical chemistry and instrumentation (HPLC, UPLC).
    3. Experienced with structural biology preferred.
    4. Prior exposure to analytical method development and validation for regulatory filing is a plus.
    5. Excellent communication and organization skills.
  • 要求資格
    1. A PhD degree in Chemistry, Biotech or Biochemistry with more than 1-3 years of postgraduate training (industry R&D experience) preferred.
  • 人數:2-3
  • 上班地點:Shanghai Henlius Biotech Co. Ltd
  • 職務內容
    1. Develop project level’s short-, mid-, and long-term project plans including project yearly budget and task.
    2. Maintain, track and manage the integrated project plan to enable accurate reporting and decision making for high management team and relevant functions.
    3. Build a high performing project team and keeps team members accountable for the project delivery.
    4. Coordinate and manage a cross-functional team to deliver assigned clinical project activities to time, cost and high quality in line with ICH/GCP and Henlius relevant SOPs.
    5. Collaborate with the internal and external stakeholders to optimize functional and cross-functional processes.
  • 需要條件
    1. At least 6 years’ experience in clinical trials management.
    2. Extensive knowledge of clinical operations and project management.
    3. Understanding of the drug development and clinical study process, familiar with ICH / GCP guidelines and clinical study related regulations.
    4. Ability to think strategically when planning, managing teams, and managing processes.
    5. Excellent communication, relationship building and problem solving skills.
    6. Excellent knowledge of spoken and written English
    7. Proactive and strong sense of responsibility;
    8. Self-disciplined, able to work independently and to work under pressure
    9. High level of enthusiasm and good team work spirit;
    10. Good communication skills and patience;
    11. Integrity and preciseness.
  • 要求資格
    1. Bachelor degree in medical, pharmacological or biological relevant discipline; Advanced degree preferred.
  • 人數:1
  • 上班地點:Shanghai Henlius Biotech Co. Ltd
  • 職務內容
    1. Responsible for leading and managing Henlius Biopharma’s quality system improvement initiative across all departments and functions to ensure that quality initiatives and quality plans are executed and maintained in full compliance with CGMP requirements. This includes addressing issues from quality management oversight and helping the site management team to execute effectively the quality enhancement activities.
    2. Ensure an effective review on suitability and effectiveness of quality system at defined intervals.
    3. Direct and support the resolution of quality problems in the facility activities so that they are consistent with the industry and company quality standards.
    4. Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
    5. Identify and support continuous improvement projects in collaboration with site management team with objective of achieving quality, reliability and cost improvements.
    6. Attend preparation and execution of internal, external and regulatory audits on the site.
    7. Participate in or manage quality assessments related to introduction of new products into the facility.
    8. Review and approve high level quality documents
    9. Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.
    10. Ensure that company executive leadership team is well kept informed of all critical and major quality issues which may have an adverse effect on the product quality.
    11. Perform review of compliance performance at department and individual level and propose corrective actions.
    12. Provide coaching and direction for QA managers and team leaders, and provide training to relevant staff, as requested.
    13. Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.

    14. Provide quality support and expertise in the GMP projects such as non-conformance remediation plan, tech transfers, GMP facility projects, and the launch of new products.

    15. Provide support to sites as part of the regulatory inspections and external audits.
    16. Contribute significantly to the development of best practice within the scope of GMP compliance and regulatory requirements; facilitate interaction and exchange of best practices with other departments and functional areas.
    17. Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.
    18. Representing the quality team, works closely with the heads of other line operations.
    19. Take strategic and leadership responsibilities in bridging between the site and the corporate quality management team.
  • 需要條件
    1. Expert in quality system implementation & improvement, which include but are not limited to Product Release & Production Batch Record, SOP, Training, External & Internal Audit, Regulatory Inspection, Change Control, Data Integrity, Customer Complaint Management, Qualification & Validation, Technology Transfer (Manufacturing Process & Analytical Method), Deviation and OOS Investigation, Quality Risk Management, External Supplier/Vendor Quality System, Quality Agreement, Quality Metrics, and CAPA Management for Non-conformance.
    2. Demonstrated leadership & experience in staff skill development, performance appraisal and department budget management.
    3. Experience in transverse management without direct hierarchical authority or supervision.
    4. Results orientated
    5. Strong leadership
    6. Communication Skill
    7. People management and development Skill
  • 要求資格
    1. Advanced degree (MS or PhD) within pharmacy, biology or engineering and with at least 10 years’ managerial experience in a production and/or quality function in the biotechnology / pharmaceutical industry.
  • 人數:1
  • 上班地點:Shanghai Henlius Biotech Co. Ltd
  • 職務內容
    1. Lead and manage the PD organization, including PDU (Cell Culture), PDD (Purification), Formulation Development, and BAD(Biology Ananlysisi Development) of Shanghai Henlius (located in Shanghai, China), to achieve the strategic goals of the company.
    2. Lead and manage the Cell Line and Process Development group of Henlix-USA (located in Fremont, CA, USA).
    3. Support the development of various biosimilar, biobetter, and fast-follower products for local (China) and global regiulatory filings and commercialization.
    4. Recruit, train, and develop talents at all levels in the PD organization.
    5. Coordinate with the Manufacturing organization for tech transfer of developed manufacturing process to support late-phase and commercial manufacturing.
    6. Provide technical guidance and support to the Manufacturing group.
    7. Lead the PD groups to conduct extensive comparability (for process changes) and similarity (for establishing biosimilarity) studies according to EMA, FDA and ICH guidelines.
    8. Establish solid documentation systems within the PD organization, to record and document all PD studies to support regulatory filings and inspections, as well as business development and financing projects.
    9. Adopt and/or develop new PD technologies for improvement of quality, speed, and/or cost effectiveness.
    10. Other projects and tasks assigned by the CEO or CSO of Henlius.
  • 需要條件
    1. Excellent communication skills and be bilingual for both English and Mandarin Chinese (proficient in both written and verbal aspects).
    2. Extensive experience in the process development for therapeutic antibody and/or recombinant protein products that are produced by a CHO-based bioprocess.
    3. Be familiar with various FDA and ICH guidelines with regard to the development of biologics for therapeutic indications.
    4. Be goal-oriented and resourceful, capable of serving as a role model of the corporate culture emphasizing on quality, speed and innovation.
  • 要求資格
    1. A Ph.D. degree in biological sciences, biochemistry, or bioengineering with at least 10 years of related technical and managerial experiences in the biotech or biopharma industry.
  • 人數:1
  • 上班地點:Shanghai Henlius Biotech Co. Ltd
  • 職務內容
    1. Manage Technical Service function to achieve company strategic goals. Responsible for providing technical solutions for drugs GMP manufacturing from IND to commercial manufacturing.
    2. Support the process development and GMP manufacturing for various biosimilar, biobetter, ADC and fast-follower products for local (China) and global regulatory filings, clinical trials and commercialization.
    3. Recruit, train, and develop talents at all levels for Technical Service function. Keep facility and personnel GMP compliance. Manage Technical service lab and EHS compliance.
    4. Bridge R&D and Manufacturing department by reviewing process parameters, writing GMP/technical documentations, scaling up/engineering runs and tech transfer well developed manufacturing process to support late-phase and commercial manufacturing.
    5. Provide technical guidance, supports and troubleshooting to manufacturing group. Offer scientific and technical suggests and solutions for QA GMP OOS/derivation investigation and CAPA.
    6. Establish solid documentation systems and support SOP, BPR, Technical Transfer Protocol, IND/NDA documentations writing according to QA, EMA, FDA and ICH guidelines.
    7. Test new process equipment and technology, provide optimization and continuous improvement for PD, Technical transfer and GMP manufacturing.
    8. Present Henlius technology excellence during external conferences or industrial activities. Train staff internally, qualify staff technical knowledge and skills.
    9. Responsible for manufacturing automation and data collection.
    10. Other projects and tasks assigned by the CEO or COO of Henlius.
  • 需要條件
    1. Excellent communication skills and be bilingual for both English and Mandarin Chinese (proficient in both written and verbal aspects).
    2. Extensive experience in the process development for therapeutic antibody and/or recombinant protein products that are produced by a CHO-based bioprocess.
    3. Relevant GMP manufacturing experiences for biologics, and/or facility development in compliance with CFDA, EMA or US FDA GMP standards.
    4. Be familiar with various FDA and ICH guidelines with regard to the development of biologics for therapeutic indications.
    5. Be goal-oriented and resourceful, capable of serving as a role model of the corporate culture emphasizing on quality, speed and innovation.
  • 要求資格
    1. A Ph.D. degree in biological sciences, biochemistry, or bioengineering with at least 5 years of related technical and managerial experiences in the biotech or biopharma industry.
  • 人數:1
  • 上班地點:Shanghai Henlius Biotech Co. Ltd
  • 職務內容
    1. Be responsible for the cGMP operations of biologics manufacturing facilities including upstream cell culture antibody production, downstream protein purification, fill finish and supply chain management.
    2. Be supportive in biologics cGMP facility development from design, construction, validation to start-up.
    3. Establishes and optimizes manufacturing policies and cGMP document systems including standard operation procedures and manufacturing batch records.
    4. Leads manufacturing process trend analysis and prepares reports using advanced statistical tools for continuous improvement of manufacturing and its process.
    5. Manages strictly the production system and activities according to the US, EU, Chinese GMPs, leads the subordinates and all of manufacturing staff to strictly carry out the related work accordingly.
    6. Checks the production system, quality system and improve the scheme of technical system and equipment maintenance system.
    7. Evaluates and controls the cost of production, quality, process and capacity; Develops and controls department budgets.
    8. Ensures the EHS in manufacturing facilities.
    9. Be responsible for planning department head count and managing performance; leading, managing, training and checking day-to-day activities of the manufacturing.
    10. Prepares the readiness for regulatory inspections on the cGMP facility and biologics manufacturing process.
    11. Any other ad hoc tasks assigned by line manager.
  • 需要條件
    1. Minimum 8 years related experiences of manufacturing in a global biopharmaceutical company; and minimum 5 years experiences at managerial level or above.
    2. Familiar with Biotech industry and monoclonal antibody drug manufacturing.
    3. Have in-depth knowledge and hands-on experiences with US, EU and Chinese GMPs regulatory and quality standards requirements for biologics manufacturing.
    4. Understanding of business objectives and the impact of operations and technical activities on those objectives.
    5. Rich experiences in production management, equipment management, quality management and a regulatory inspection of biologics is highly preferred.
    6. Excellent verbal and written communication skills in both Chinese and English.
    7. Result-oriented approach;
    8. Excellent organizing ability, communication and interpersonal skills at all levels;
    9. Strong influencing skills;
    10. Strong analytical/problem solving skills;
    11. Ability to lead groups including suborinate, peer, and site leadership。
  • 要求資格
    1. Educated to bachelor, master degree level or equivalent, preferably in related major in biochemical engineering, biotechnology, and biological sciences.