Jobs

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 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 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 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 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 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 Jobs at http://www.jhlbiotech.com/careers.php
Job Information

Jobs available at link http://www.jhlbiotech.com/careers.php



Title (Senior) Research fellow at BGI
Location China
Job Information

BGI overseas hiring 华大海外招聘

Position

(Senior) Research fellow,Molecular and cellular immunologist for T cell-based immunotherapy

Responsibilities

· Responsible for the R&D related work of cancer immunotherapy

· Platform development for engineered T cells (CAR-T, TCR-T)

· Implementation of functional assays for human immune cells (T cells, DC etc.)

· Responsible for tetramer generation/research and platform establishment, rapid development of the experimental procedure

· Guide team members to carry out work and build product pipeline;

· Draft patent paper work, grant application and scientific paper writing and publishing.

· Responsible for the collaboration/CRO communication worldwide

Qualifications/Requirement

· Ph.D. degree majored in biology, immunology or related field. Strong English reading and writing skills.

· With abundant experience in cell-based functional assays and experimental techniques of immunology, such as primary cell culture, flow cytometric analysis, ADCC&CDC, cytokine assay, etc.

· Familiar with molecular and cellular biology experiments, such as engineering TCR, CAR-T, expression library construction and screening; lentiviral transduction

· With lab experience in protein purification/chemistry, SDS-PAGE, HPLC etc. is preferred;

· Have high level SCI literature published experience is preferred;

· Strong academic thinking skills and able to design and advance project as per objectives;

· Work proactively to resolve issues, with strong implementation skills and highly adaptable. Able to comprehend papers and learn new skills;

· Good team player and management skills. Down-to-earth attitude and highly responsible.

Work Place: BGI, Shenzhen, China

Contact: BGI.overseasrecruitment@gmail.com



Title (Senior) Research fellow (China) or Consultant (U.S.) at BGI
Location China/US
Job Information

BGI overseas hiring 华大海外招聘

Position

(Senior) Research fellow (China) or Consultant (U.S.), HLA immunopeptidomics LC-MS

Responsibilities

· Responsible for the set-up, advancement and application of the tumor cells mass spectrometry assay with particular focus on HLA class I immunoaffinity procedures, high resolution LC-MS/MS analysis and bioinformatics.

· Participate and lead in technology development and implementation by exploring advancement to the workflow of HLA class I immunopeptidome.

· Participate in all phases of mass spectrometry laboratory operations including technology evaluations, the development of sample preparation and separation methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.

· As a strong collaborator develop deep partnerships with Immunogenicity Scientists working on cell preparation or assessing immunogenicity project risks as well as in-house LCMS team members.

Qualifications /Requirement

· Qualified applicants hold a Ph.D. with post-doctoral experience including experience in industry, ideally in the application of LC-MS to assess immunogenicity risks of protein therapeutics.

· Expertise in development and implementation of mass spectrometry based immunopeptidomics methods.

· Expertise in mass spectrometry based proteomics.

· Experience and knowledge in operation of QExactive mass spectrometers and associated control and data analysis software systems.

· Knowledge and application of complex sample preparation methodologies as applied to quantitative protein mass spectrometry workflows techniques including immuno-analytical techniques.

· Good understanding of protein biochemistry.

Work Place: BGI, Shenzhen, China or U.S. for a consultant

Contact: BGI.overseasrecruitment@gmail.com



Title BGI-(Senior) Research Fellow
Job Information

BGI overseas hiring 华大海外招聘

Position

(Senior) Research fellow, lab automation for cell processing and manufacturing

Responsibilities

· Implementation of lab automation infrastructure for cell and gene therapy, such as viral infection, human cell isolation, cell culture processing and maintenance

· Oversee and strategic plan for biomanufacturing engineering for cell and gene therapy

· Responsible for the establishment of lab automation processing in GMP cell manufacturing facility

· Research and develop in-house hardware and software for automated platforms

· Responsible for maintenance and upgrade of precious laboratory equipment/devices

Qualifications/Requirement

· Ph.D. degree or master degree with more than five years working experience in lab automation and cell processing/manufacturing

· Experience with biology laboratory automation, biomedical instrument manufacturing engineering, and other related experience and professional

· Work experience with construction and design of cell therapy equipment is preferred

Work Place: BGI, Shenzhen, China or U.S. for a consultant

Contact: BGI.overseasrecruitment@gmail.com



Title BGI Research-Antibody Discovery
Job Information

BGI Research – Antibody Discovery

Job Description:

We are seeking a senior level researcher to join our genomics-based Antibody Discovery Program. We are studying both classical antibodies and novel single domain antibodies, such as those from camels and sharks. The successful candidate will execute laboratory research to develop novel antibody technologies and contribute to our pipeline of antibody drug research.

Job Requirements:

1) A PhD degree and 3+ years’ experience in molecular biology, biochemistry, or related discipline, or a MS degree plus 8+ years research experience.

2) The candidates should have expertise in molecular cloning, protein biochemistry, and protein engineering, including preferably experience with one or more display methodologies.

3) Research experience with antibodies is required. A background in protein structural biology, protein expression, antibody affinity maturation or antibody-drug conjugation research is preferred.

4) Ability to multitasking and manage multiple projects simultaneously.

5) Strong interpersonal and communication skills are needed for this role. Management experience is preferred

6) English/Chinese bilingual preferred but not required

Work Place: BGI, Shenzhen, China or U.S. for a consultant

Contact: BGI.overseasrecruitment@gmail.com



Title CMC Leader at Tessa Therapeutics
Location Singapore
Job Information

CMC Leader

Tessa Therapeutics is seeking a CMC leader at director level to lead the process/analytical development and validation, as well as product characterization and manufacturing process capability analysis, for BLA filing for our cell therapy products for cancer patients. The individual will also work closely with Regulatory Affairs, Manufacturing, and Research teams at Tessa. This position is located in Tessa’s corporate headquarter in Singapore.

Job Description

· Lead a dynamic and matrix team with members from various functional groups to achieve scientific excellence and innovation, while adopting development stage-appropriate practices, in the CMC areas of process, analytical, and formulation development and manufacturing process capability analysis and supply chain qualification.

· Define CMC strategies, deliverables, resource requirement, and timelines to support product development milestones, from preclinical studies, IND filing, clinical study supply, BLA filing, to commercialization, product life cycle management

· Leverage Quality-by-Design (QbD), Process Analytical Technologies (PAT), and risk-based approaches to develop robust processes and analytical procedures to ensure long-term success in manufacturing cell therapy products for vein-to-vein delivery to patients

· Stay current with regulatory requirements and new technologies/methodologies in CMC areas, designs and executes experiments to provide required information and data for regulatory filing, process capability analysis, and investigations.

· Interacts with regulatory authorities through conferences and regulatory filings/meetings, and anticipates regulatory changes and develops proactive strategy accordingly

· Coaches a highly effective and scientifically strong team for ensure efficient technical transfer of processes and assays to manufacturing and quality control teams, including to new GMP locations

· Responsible for supporting and reviewing the CMC sections in regulatory submissions including both pre-approval and post approval submissions such as IND, NDA/BLA, amendments/supplements, annual reports, product characterization study reports, comparability protocols and reports, etc.

· Participate in the product development teams, providing clear and solid recommendations for CMC strategies and execution plans

· Manage external CMC activities in collaboration or outsourcing cases

Qualification(s):

· PhD or Master in Life Science (e.g. Immunology, Biochemistry, Biotechnology, Biology) or equivalent

· 5+ years proven successful CMC experience in biopharmaceuticals in either cell processing or analytical field under cGMP environment, preferably in leading diversified technical teams

· Excellent working knowledge/experience in CMC areas for cell therapies or biologicals, especially in applying QbD, PAT, DOE, and risk assessment approaches to ensure CMC excellence and identify and control CQAs and CPPs

· Familiar with approval processes for IND and BLA, comparability protocols, and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements

· Highly developed inter-personal skills and verbal/written communication

· Strong problem solving and critical thinking skills

To apply or for inquiry, please contact sjshih@tessatherapeutics.com.