The Skyline Team

At Skyline Therapeutics, we are turning our passion for science and our expertise in gene therapy into promising new treatments. Our work is guided by a commitment to fulfilling the unmet needs of patients. It urges us to pursue scientific breakthroughs that can only be possible through relentless innovation, a constant strive for quality, and team collaborations.

Join us

The fast-growing Skyline team provides a variety of opportunities for individuals to learn, grow, and create scientific excellence. Join us in our efforts to discover, develop and deliver transformative therapies that could bring life-changing benefits to patients.

Job openings
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Position Location Job Details
  • Medical Manager Shanghai

    Key Responsibilities:

    ·Lead the development of Clinical Development Plan (CDP) for assigned projects

    ·Develop clinical study protocols and implementation plan, monitor study execution and respond to the medical questions

    ·Be a key member to drive the IND/NDA submission and approval. Working closely with Regulatory Affairs to support regulatory communications with the agency

    ·Liaison with KOLs, clinical investigators, clinicians, scientists, and experts in clinical development activities, including but not be limited to, strategy, trial design, result interpretation and communication

    ·Oversee and manage external service providers

    ·Support clinical data review and analyses

    ·Support preparation of study related documents

    ·Closely work with internal groups like Process Development, Research, Business Development, Legal, etc. to ensure the alignment and progress of the projects

    Qualifications:

    ·Medical degree (M.D.) with ~5 years or more experience in clinical research (or combined experience in medical practice and clinical research)

    ·Experience of authoring a full clinical study protocol is preferred

    ·Good understanding of relevant regulations and guidelines by FDA, NMPA, ICH, etc.

    ·In-depth understanding/experience of Phase II – III drug development, knowledge/understanding/experience of Phase I is a plus

    ·Experience and/or strong interest in gene therapy is a plus

    To apply, send us email with your resume to career@skytx.com
  • Clinical Project Manager Shanghai

    Key Responsibilities:

    ·Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts

    ·Execute and deliver assigned studies according to business needs (timeline and cost) and quality requirements as defined in the study protocol

    ·Ensure the quality of the data

    ·Perform co-monitoring visits, if appropriate

    ·To be responsible for working to coordinate for audits and take responsibility for the responses and corrective actions to audit finding

    ·Provides training and coaching to CRAs regarding all aspects of the clinical trial process

    ·Proactively identifies and resolves issues and participates in process improvement initiatives as required

    ·Performs other duties as assigned

    Qualifications:

    ·Education: BS/BA degree in life sciences or health related field

    ·Experience: Above 5 years of clinical trial related experience

    ·Skillsets:
    a) Ability to adapt and thrive in a dynamic environment
    b) Knowledge of Good Clinical Practice, ICH guidelines
    c) Effective oral/written communication skills, demonstrated ability to balance multiple competing priorities
    d) Effective planning, critical thinking and problem solving as well as strong organizational skills

    To apply, send us email with your resume to career@skytx.com
  • Clinical Research Associate Shanghai

    Key Responsibilities:

    ·Evaluate potential sites and provide PM with recommendations for selection of qualified sites

    ·Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans

    ·Prepare and manage the clinical trial agreements with investigators/sites

    ·Monitor and report the project status at the sites in a timely manner

    ·Maintain essential documentation in compliance with ICH-GCP, local regulations both in the office and at site

    ·Manage study supplies (ISF, CRF, etc.), drug supplies and drug accountability at study sites

    ·Assist the investigator for auditing/inspection of project

    ·Ensure completeness and quality of data in the investigational sites

    ·Proactively identify study-related issues and escalates as appropriate

    ·Performs other duties as assigned

    Qualifications:

    ·Bachelor’s degree or above in a scientific or health-related field

    ·CRA: above 2 years of relevant clinical research experience

    ·Senior CRA: above 3 years of monitoring experience. Demonstrate leadership skill, mentor, and coach capability, able to work independently

    ·Knowledge of Good Clinical Practice, ICH guidelines

    ·Fluent in English

    To apply, send us email with your resume to career@skytx.com
  • Scientist, In Vivo Pharmacology Shanghai

    Key Responsibilities:

    ·Execute in vivo studies using different animal models following protocols and study designs

    ·Perform animal necropsies including perfusion, tissues and blood collections, knowledge of tissues processing for IHC and in situ hybridization will be a plus

    ·Analyze and interpret results with high quality and reproducibility in a timely manner

    ·Participate in discussions in cross-disciplinary team and program meetings

    ·Contribute to writing study reports, study protocols, SOPs, and regulatory filings

    ·Finish the other tasks assigned by the supervisor

    Qualifications:

    ·A minimum of a bachelor with 2 years or a Master with 1 year of professional working experience in vivo drug discovery

    ·Working knowledge in in vivo pharmacology and strong expertise in animal handlings and various routes of drug administrations

    ·Ability to follow study protocols and execute in vivo studies with minimal supervision

    ·Self-motivated, organized, capable of working in a collaborative/group environment

    ·Ability to function and communicate effectively in a highly productive multi-disciplinary environment

    ·Excellent communication skills and enjoy work in a fast-paced and highly interactive environment

    To apply, send us email with your resume to career@skytx.com
  • Investigator, Molecular Biology Shanghai

    Key Responsibilities:

    ·Design, construct, and optimize AAV transgenes for various pipeline programs

    ·Characterize the expression and activity AAV transgene in cells and animal tissues, optimize the transgene based on program need

    ·Develop and validate assays for characterizing the products encoded by AAV transgenes

    ·Plan and write protocols for in vitro characterization of AAV vectors

    ·Carry out small scale production of AAV vectors using triple transfection for both in vitro and in vivo studies

    ·Perform AAV vector purification, evaluate AAV vector quality by qPCR, silver staining, denaturing gel, and other assays

    ·Write, execute, and troubleshoot protocols, adapt new protocols into practice

    ·Analyze data from studies, summarize them and write study reports, and present results in various meetings

    ·Finish the other tasks assigned by the supervisor

    Qualifications:

    ·Ph.D. in Molecular/Cellular Biology/Biochemistry or related discipline

    ·2-5 years of hands-on experience in DNA cloning, transfection, protein expression and characterization

    ·Extensive knowledge and experience with molecular and cellular techniques

    ·Excellent track record in AAV transgene design, optimization, and characterization

    ·Experience with qPCR, PRT-PCR, and digital droplet PCR

    ·Outstanding communication and problem-solving skills

    ·Significant experience with managing collaborations with other laboratories and/or CROs

    ·Ability to be highly productive in a fast-paced, fluid, and team-oriented work environment

    ·Strong publication record in peer-reviewed journals

    To apply, send us email with your resume to career@skytx.com
  • Scientist, Upstream Process Development Shanghai

    Key Responsibilities:

    ·Execute in vivo studies using different animal models following protocols and study designs

    ·Perform animal necropsies including perfusion, tissues and blood collections, knowledge of tissues processing for IHC and in situ hybridization will be a plus

    ·Analyze and interpret results with high quality and reproducibility in a timely manner

    ·Participate in discussions in cross-disciplinary team and program meetings

    ·Contribute to writing study reports, study protocols, SOPs, and regulatory filings

    ·Finish the other tasks assigned by the supervisor

    Qualifications:

    ·A minimum of a bachelor with 2 years or a Master with 1 year of professional working experience in vivo drug discovery

    ·Working knowledge in in vivo pharmacology and strong expertise in animal handlings and various routes of drug administrations

    ·Ability to follow study protocols and execute in vivo studies with minimal supervision

    ·Self-motivated, organized, capable of working in a collaborative/group environment

    ·Ability to function and communicate effectively in a highly productive multi-disciplinary environment

    ·Excellent communication skills and enjoy work in a fast-paced and highly interactive environment

    To apply, send us email with your resume to career@skytx.com
  • Scientist, Downstream Process Development Shanghai

    Key Responsibilities:

    ·Execute in vivo studies using different animal models following protocols and study designs

    ·Perform animal necropsies including perfusion, tissues and blood collections, knowledge of tissues processing for IHC and in situ hybridization will be a plus

    ·Analyze and interpret results with high quality and reproducibility in a timely manner

    ·Participate in discussions in cross-disciplinary team and program meetings

    ·Contribute to writing study reports, study protocols, SOPs, and regulatory filings

    ·Finish the other tasks assigned by the supervisor

    Qualifications:

    ·A minimum of a bachelor with 2 years or a Master with 1 year of professional working experience in vivo drug discovery

    ·Working knowledge in in vivo pharmacology and strong expertise in animal handlings and various routes of drug administrations

    ·Ability to follow study protocols and execute in vivo studies with minimal supervision

    ·Self-motivated, organized, capable of working in a collaborative/group environment

    ·Ability to function and communicate effectively in a highly productive multi-disciplinary environment

    ·Excellent communication skills and enjoy work in a fast-paced and highly interactive environment

    To apply, send us email with your resume to career@skytx.com
  • Scientist, Analytical Development Shanghai

    Key Responsibilities:

    ·Support method development, qualification, and transfer of biochemical, immunological, and molecular methods relevant for gene therapy products

    ·Design and execute experiments to support development of qualitative and quantitative assays for gene therapy process development as well as product characterization

    ·Conduct experiments to support vector characterization, in-process material testing, and stability studies in a timely manner

    ·Lead the development of robust assays in support of drug substance and drug product manufacturing and release testing

    ·Support analytical method investigations and troubleshooting

    ·Provide regular updates to internal team members and write SOPs, development reports, and characterization protocols, qualification protocols and reports as needed

    ·Maintain laboratory activities according to GMP compliance as needed

    ·Train colleagues and associates when needed

    Qualifications:

    ·PhD with 0-1+ years; MS with 1-2+ years; BS with 3-4+ years of education field in cell biology, virology, immunology, biochemistry, or molecular biology is preferred

    ·Direct training and laboratory experience in gene therapy products are preferred

    ·The candidate should have 2-5 years’ experience developing novel analytical methods and qualifying assays for the characterization and release of gene therapy products and experience in working in a regulated environment. Extensive experience in functional cell-based assay development is preferred

    ·The candidate should understand regulatory guidelines and compliance

    ·The candidate will be responsible for the implementation of advanced analytical technologies and/or automated methods

    ·The candidate should be organized, motivated and have excellent communication and interpersonal skills within a cross-functional environment

    ·The candidate should have strong documentation and organizational skills relevant for CMC and Analytical development/Quality Control

    ·The candidate should have experience operating PCR, ddPCR, qPCR, plate readers, confocal microscope, HPLC, flow cytometry, automation, and other laboratory equipment

    To apply, send us email with your resume to career@skytx.com
  • Quality Assurance Specialist Hangzhou

    Key Responsibilities:

    ·Execute in vivo studies using different animal models following protocols and study designs

    ·Perform animal necropsies including perfusion, tissues and blood collections, knowledge of tissues processing for IHC and in situ hybridization will be a plus

    ·Analyze and interpret results with high quality and reproducibility in a timely manner

    ·Participate in discussions in cross-disciplinary team and program meetings

    ·Contribute to writing study reports, study protocols, SOPs, and regulatory filings

    ·Finish the other tasks assigned by the supervisor

    Qualifications:

    ·A minimum of a bachelor with 2 years or a Master with 1 year of professional working experience in vivo drug discovery

    ·Working knowledge in in vivo pharmacology and strong expertise in animal handlings and various routes of drug administrations

    ·Ability to follow study protocols and execute in vivo studies with minimal supervision

    ·Self-motivated, organized, capable of working in a collaborative/group environment

    ·Ability to function and communicate effectively in a highly productive multi-disciplinary environment

    ·Excellent communication skills and enjoy work in a fast-paced and highly interactive environment

    To apply, send us email with your resume to career@skytx.com
  • Quality Control Specialist Hangzhou

    Key Responsibilities:

    ·Perform routine tests in a GMP QC lab, such as ELISA, RT-PCR, ddPCR, HPLC-based assays, viral infectivity, routine maintenance of adherent and suspension cell cultures and various cell-based assays as required

    ·Generate internal and external documents such as analysis report, COAs, summary of reports, and SOPs

    ·Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending analysis

    ·Work closely with Manufacturing and Quality Assurance staff to resolve quality issues, including experiment troubleshooting, and data interpretation

    ·Work on project teams developing and improving assays

    ·Training other QC scientists through established on-the-job training processes

    ·Additional duties as assigned; work under general supervision to meet project goals

    Qualifications:

    ·B.S. in biology, biotechnology or related life sciences field with 4+ years of relevant experience working in an analytical or QC laboratory – OR – M.S. in molecular biology, cell biology, immunology or related field with 2-3 years of relevant experience working in an analytical or QC laboratory

    ·Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Control function with a strong familiarity of general GMP practices

    ·Experience in writing SOPs of test methods as well as documentation for method transfer and method qualification/validation

    ·Experience with the transfer/qualification/Validation of GMP assays

    ·Extensive experience with biochemistry and biological assays, as well as generating/reviewing the documentation that supports such work

    ·Capability and skills to apply scientific knowledge and regulatory principles to solve operational, as well as routine quality control problems

    ·Experience with common compendial testing methods is a plus

    To apply, send us email with your resume to career@skytx.com
  • Production Specialist Hangzhou

    Key Responsibilities:

    ·Execute in vivo studies using different animal models following protocols and study designs

    ·Perform animal necropsies including perfusion, tissues and blood collections, knowledge of tissues processing for IHC and in situ hybridization will be a plus

    ·Analyze and interpret results with high quality and reproducibility in a timely manner

    ·Participate in discussions in cross-disciplinary team and program meetings

    ·Contribute to writing study reports, study protocols, SOPs, and regulatory filings

    ·Finish the other tasks assigned by the supervisor

    Qualifications:

    ·A minimum of a bachelor with 2 years or a Master with 1 year of professional working experience in vivo drug discovery

    ·Working knowledge in in vivo pharmacology and strong expertise in animal handlings and various routes of drug administrations

    ·Ability to follow study protocols and execute in vivo studies with minimal supervision

    ·Self-motivated, organized, capable of working in a collaborative/group environment

    ·Ability to function and communicate effectively in a highly productive multi-disciplinary environment

    ·Excellent communication skills and enjoy work in a fast-paced and highly interactive environment

    To apply, send us email with your resume to career@skytx.com