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Title VP of Quality System Compliance at Shanghai Henlius Biotech Inc
Job Information

Job Title: VP of Quality System Compliance

Reporting to: CEO

Opportunity Highlights: This role is responsible for providing expert guidance and direction on all compliance aspects regarding quality system operation in the GMP and ICH compliant Henlius Biopharmaceuticals for new and existing products. This position will act as the Subject Matter Expert (SME) within the organization with the main objective of improving the overall compliance culture throughout the Henlius facilities and sites.  This position will be responsible for advising managers and other colleagues on compliance issues and will lead compliance projects when necessary.  Primary duties will include identifying the root cause of compliance issues through internal / external audits and regulatory inspections, deviations and OOS investigations, participation in batch review and change control dialogue.  Serving the quality system SME, this individual will be responsible for influencing management team on all compliance issues and for developing best practices and action plans according to the GMP regulatory requirements and company quality standards.  The incumbent will also be responsible for advising management on internal, external audits and regulatory inspections, with continued business growth.  He or she will also play an integral role in a cross functional team focused on new product development.

In summary, this is a rare and excellent opportunity to join Shanghai Henlius Biopharmaceuticals during a period of rapid development and growth. This position is highly influential and critical to achieving compliance improvement and as a result contributing to the organization’s strategic goals for continued growth and commercial success.

Key Responsibilities:

  • 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.
  • Ensure an effective review on suitability and effectiveness of quality system at defined intervals.
  • Direct and support the resolution of quality problems in the facility activities so that they are consistent with the industry and company quality standards.
  • Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
  • Identify and support continuous improvement projects in collaboration with site management team with objective of achieving quality, reliability and cost improvements.
  • Attend preparation and execution of internal, external and regulatory audits on the site.
  • Participate in or manage quality assessments related to introduction of new products into the facility.
  • Review and approve high level quality documents
  • Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.
  • 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.
  • Perform review of compliance performance at department and individual level and propose corrective actions.
  • Provide coaching and direction for QA managers and team leaders, and provide training to relevant staff, as requested.
  • Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.
  • 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.
  • Provide support to sites as part of the regulatory inspections and external audits.
  • 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.
  • Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.
  • Representing the quality team, works closely with the heads of other line operations.
  • Take strategic and leadership responsibilities in bridging between the site and the corporate quality management team.

Qualifications:

  • 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.

Experience and Knowledge:

  • 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.
  • Demonstrated leadership & experience in staff skill development, performance appraisal and department budget management.
  • Experience in transverse management without direct hierarchical authority or supervision.

Key Competencies Required:

  • Results orientated
    • Demonstrated ability to achieve results and manage others to achieve corporate, site and functional objective
    • Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation
    • Team performance complemented by development of skills and performance of individual team members
  • Strong leadership
    • Strategy development and execution
    • Combined strategic and operational thinking
    • Focus on goals
 with sound judgment
    • Ability to manage multiple priorities and act with a sense of urgency
    • Pro-active and creative by designing new processes and implementation of those to promote process improvement continuously
  • Communication Skill

    • Ability to work in highly diversified cultures
    • Ability to work in a matrix, multicultural environment
  • People management and development Skill

    • Collaborates and communicates
    • Leads others to work together
    • Develops team capabilities and staff performance
    • Rewards and recognizes desired performance
    • Driven by building interpersonal and a proven team builder

 

 

Please send resume to ekang@henlix.com



Title VP, Process Development at Shanghai Henlius Biotech, Inc.
Job Information

Job Description

  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.

 

Qualification

  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.
  2. Excellent communication skills and be bilingual for both English and Mandarin Chinese (proficient in both written and verbal aspects).
  3. Extensive experience in the process development for therapeutic antibody and/or recombinant protein products that are produced by a CHO-based bioprocess.
  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.

Please send resume to ekang@henlix.com

 



Title Director of Quality System Compliance at Shanghai Henlius Biotech Inc
Job Information

Job Title: Director of Quality System Compliance

Reporting to: Senior Vice President of Quality & Chief Quality Officer

Opportunity Highlights: This role is responsible for providing expert guidance and direction on all compliance aspects regarding quality system operation in the GMP and ICH compliant Henlius Biopharmaceuticals for new and existing products. This position will act as the Subject Matter Expert (SME) within the organization with the main objective of improving the overall compliance culture throughout the Henlius facilities and sites.  This position will be responsible for advising managers and other colleagues on compliance issues and will lead compliance projects when necessary.  Primary duties will include identifying the root cause of compliance issues through internal / external audits and regulatory inspections, deviations and OOS investigations, participation in batch review and change control dialogue.  Serving the quality system SME, this individual will be responsible for influencing management team on all compliance issues and for developing best practices and action plans according to the GMP regulatory requirements and company quality standards.  The incumbent will also be responsible for advising management on internal, external audits and regulatory inspections, with continued business growth.  He or she will also play an integral role in a cross functional team focused on new product development.

In summary, this is a rare and excellent opportunity to join Shanghai Henlius Biopharmaceuticals during a period of rapid development and growth. This position is highly influential and critical to achieving compliance improvement and as a result contributing to the organization’s strategic goals for continued growth and commercial success.

Key Responsibilities:

  • 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.
  • Ensure an effective review on suitability and effectiveness of quality system at defined intervals.
  • Direct and support the resolution of quality problems in the facility activities so that they are consistent with the industry and company quality standards.
  • Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
  • Identify and support continuous improvement projects in collaboration with site management team with objective of achieving quality, reliability and cost improvements.
  • Attend preparation and execution of internal, external and regulatory audits on the site.
  • Participate in or manage quality assessments related to introduction of new products into the facility.
  • Review and approve high level quality documents
  • Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.
  • 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.
  • Perform review of compliance performance at department and individual level and propose corrective actions.
  • Provide coaching and direction for QA managers and team leaders, and provide training to relevant staff, as requested.
  • Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.
  • 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.
  • Provide support to sites as part of the regulatory inspections and external audits.
  • 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.
  • Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.
  • Representing the quality team, works closely with the heads of other line operations.
  • Take strategic and leadership responsibilities in bridging between the site and the corporate quality management team.

Qualifications:

  • 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.

Experience and Knowledge:

  • 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.
  • Demonstrated leadership & experience in staff skill development, performance appraisal and department budget management.
  • Experience in transverse management without direct hierarchical authority or supervision.

Key Competencies Required:

  • Results orientated
    • Demonstrated ability to achieve results and manage others to achieve corporate, site and functional objective
    • Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation
    • Team performance complemented by development of skills and performance of individual team members
  • Strong leadership
    • Strategy development and execution
    • Combined strategic and operational thinking
    • Focus on goals
 with sound judgment
    • Ability to manage multiple priorities and act with a sense of urgency
    • Pro-active and creative by designing new processes and implementation of those to promote process improvement continuously
  • Communication Skill

    • Ability to work in highly diversified cultures
    • Ability to work in a matrix, multicultural environment
  • People management and development Skill

    • Collaborates and communicates
    • Leads others to work together
    • Develops team capabilities and staff performance
    • Rewards and recognizes desired performance
    • Driven by building interpersonal and a proven team builder

 

 

Please send resume to ekang@henlix.com and hr@henlius.com



Title Research Associate at HENLIX, INC
Job Information

Research Associate, Protein Purification and Analytical

 

Fremont, CA

We are seeking a Research Associate with analytical and data analysis skills to join our R&D Bioanalytical Team. This position requires the ability of the candidate to support protein purification, analytics and characterization needs for discovery and development programs. The position will have opportunity to drive team efforts to continuously improve protein purification, protein characterization and process analytical. The individual will be required to diligently document experimental work in notebooks, and may be required to write (or may contribute to writing) SOPs and reports.

 

Requirements

  • BS/MS degree in Biochemistry, Chemistry or related field with 2-5 years of practical laboratory experience in an academic or industrial setting.
  • Background with hands-on experience in protein expression and purification.
  • Prior knowledge and familiarity of expression platforms and purification systems (e.g. AKTA, Unicorn) preferable.
  • Knowledgeable in protein analytical, and biophysical characterization methods such as HPLC (SEC, IEX, RP), capillary electrophoresis, cIEF, as well as maintaining and troubleshooting analytical equipment is a plus.
  • Strong organizational and communication skills are required
  • Self-motivated, data-driven and detail-oriented individual in a team environment is needed.
  • It is preferable that the candidate speaks Mandarin.

Benefits:

Henlix will provide competitive compensation.

Please send cover letter and resume to ekang@henlix.com



Title Scientist/Sr. Scientist at HENLIX, INC
Job Information

Scientist/Sr. Scientist, Molecular & Cell Biology and Immunology

 Fremont, CA

We are seeking an experienced and highly motivated molecular/cell biologist/Immunologist to work independently and to lead a matrix team contributing to research programs in drug discovery and product development. He/She will be responsible for running all research projects from initial proposal, evaluation, execution, towards preclinical development at our Fremont site and coordinating operations at our Taiwan and Shanghai sites.
Requirements

  • MS or Ph.D. in Molecular/Cellular Biology, and Immunology
  • Experience in antibody phage display library construction, panning and Ab engineering and characterization using ELISA, Octet/Biacore and other functional assays. Ab drug discovery experience in biopharmaceutical industry is a plus.
  • High attention to details, excellent organizational and managerial skills and the ability to work on multiple projects with tight deadlines
  • Excellent interpersonal and verbal communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company
  • Experience in animal model(especially immune-oncology tumor model) studies is desirable for additional responsibilities.
  • Willing to communicate with people from different locations at different time zones and to travel from time to time.
  • It is preferable that the candidate speaks Mandarin.

Benefits:

Henlix will provide competitive compensation.

Please send cover letter and resume to ekang@henlix.com



Title Scientist at HENLIX, INC
Job Information

Scientist, Molecular & Cell Biology and Immunology

 

Fremont, CA

We are seeking an experienced and highly motivated molecular/cell biologist/Immunologist to work independently and to lead a matrix team contributing to research programs in drug discovery and product development. He/She will be responsible for running all research projects from initial proposal, evaluation, execution, towards preclinical development at our Fremont site and coordinating operations at our Taiwan and Shanghai sites.
Requirements

  • MS or Ph.D. in Molecular/Cellular Biology, Biochemistry and Immunology.
  • Experience in antibody engineering, purification, and characterization using SDS-PAGE, SEC-HPLC, ELISA, Octet/Biacore and cell-based functional assays.
  • Experience in isolating human primary immune cell populations for in vitro functional assays.
  • Experience in antibody drug discovery in biopharmaceutical industry setting is a plus.
  • High attention to details, excellent organizational and managerial skills and the ability to work on multiple projects with tight deadlines.
  • Excellent interpersonal and verbal communications skills.
  • Willing to communicate with people from different locations at different time zones and to travel from time to time.
  • It is preferable that the candidate speaks Mandarin.

Benefits:

Henlix will provide competitive compensation.

Please send cover letter and resume to ekang@henlix.com



Title Sales Associate/Manager/Executive
Job Information

Sales Account Associate

Sales Account Manager

Sr. Sales Account Manager

Job Description:

The role of Sales Associate/Manager/Executive is to drive and support sales efforts in a given territory by implementing the sales/marketing strategies for GenScript products and services. The Sales Associate/Manager/Executive will use his/her knowledge of science and the business including corporate contacts to develop and deliver profitable initiatives and build sales.

Responsibilities:

The Sales Associate/Manager/Executive will be responsible for working with the Regional Sales Manager (RSM) and Technical Account Manager (TAM) to grow and develop an assigned sales territory for GenScript product/service lines and to achieve sales goals for the assigned territory

The Sales Associate/Manager/Executive will also work closely with their RSM, TAM team and Sales team to build the GenScript brand to meet the team’s sales objectives. The Sales Associate/Manager/Executive will work 70% of the time doing quote and lead followup, account management and 30% of the time traveling in the field making customer visits and building relationships in order to achieve the agreed monthly/quarterly/yearly sales goals.

  • Working with RSM to develop and implementation territory sales strategies and tactics for products/services, new markets and new applications.
  • Work together with the RSM, technical account managers (TAM) and Director of Sales to ensure all possible actions have been taken to secure business in a competitive environment
  • Responsible to understand the customer’s research application and match GenScript services and products to align with the customer’s research project requirements.
  • Share market knowledge with Sales, TAM and Marketing teams through weekly field feedback report.
  • Introduce GenScript to new markets –Industrial/Academic/Governmental.
  • Drive business expansion in collaboration with technical support team (TAM).
  • Build and expand a business reference network to help grow and develop new business opportunities.

Qualifications:

  • Ability to accurately forecast sales within territory on a weekly basis.
  • Academic degree in scientific disciplines, preferably life science.
  • Relevant Sales experience preferred and a high level of technical and professional expertise.
  • Knowledge of the Biological and CRO market. Emphasis on Gene Synthesis, Protein, Peptide, Bioassays, Antibody and Cell Line Products/Services.
  • Ability to operate effectively in an international business environment and the ability to succeed in such an environment.
  • Good verbal and written command of the English language. Prefer multi-lingual communication skills: German, French, Spanish, Italian, or Mandarin.

Company Overview:

GenScript is the world leader in gene synthesis, and a peptide, protein, and antibody research partner for fundamental life science research, translational biomedical research, early stage biopharmaceutical development, and synthetic biology. Since its founding in 2002, GenScript has provided services and products to scientists in more than 100 countries worldwide. GenScript is listed in Hong Kong Stock Exchange (1548.HK).

Please send your resume to

Selene Li

HR Recruiting Specialist

selenel@genscript.com