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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Nonclinical Safety

Job Category:

Scientific/Technology

All Job Posting Locations:

Shanghai, China

Job Description:

Location: Shanghai, China

Job responsibilities:

Johnson and Johnson Innovative Medicine (JJIM) Research & Development China is recruiting for a Principal Scientist/Senior Principal Scientist Bioanalysis, located in Shanghai China. The position is part of the Preclinical Sciences and Translational Safety (PSTS) China and collaborates closely with global PSTS Bioanalytical Discovery & Development Sciences (BDDS) for all programs in the JJIM China portfolio. This position is expected to provide bioanalytical scientific and operational expertise to clinical study teams to implement and execute all bioanalytical methods to evaluate PK and immunogenicity analysis. The position serves as a single point of contact between clinical development teams in China/USA and CROs to conduct assay transfer/validation from internal labs. This individual will follow the projects and support study bioanalysis and manage sample collection logistics, troubleshooting, and potentially, facilitate timely delivery of data to internal stakeholders and project teams. This individual will ensure the compliance with GLP/GCLP and other local and global regulations.

• Support China clinical trials bioanalysis needs for all modalities.

• Represent bioanalytical function in China Project Teams (CPT) and clinical study teams. Coordinate all BA related activities supporting China clinical trials and submissions.

Work together with CPT and global bioanalysis team to create bioanalytical strategy for portfolio programs, negotiate and update timelines.

Work with global BDDS team, oversee bioanalytical methods used in supporting the program. Make sure sample analysis is scheduled to meet timelines.

Collaborate with other related functions including clinical pharmacology, clinical operation, data management on JJIM clinical trials，reply to any bioanalysis related requestions, provide input in the clinical study protocol, lab manual or central lab scope of work, data transfer agreement, clinical study report etc.

As the functional contact, collaborate with quality team, global BA team, and other local clinical functions, support study-based inspections by health authorities.

Support clinical operation on HGRAO and CIQ permit application.

Work with BDDS team to facilitate reagent and sample shipments into China.

Ensure BA related submission dossier ready for NMPA CTA/NDA application. Contribute to the preparation of regulatory submissions. First point of contact for regulatory questions following filing, makes sure requested information provided to authorities on time.

• Monitor bioanalytical portion of preclinical and clinical studies (toxicology, drug metabolism and pharmacokinetics, and clinical trials) at our partner laboratories and other contract research organizations.

Monitor bioanalytical method development/transfer, provide scientific oversight.

Ensure work is performed in accordance with industry standards and guidance documents.

Ensure smooth initiation, execution, and completion of studies. Reviewing of records and reports are essential.

Provide technique training or knowledge transfer to preferred vendors, if necessary

Assure CROs fully comply with related GLP/GCLP (NMPA/FDA/OECD) and HGRAO regulations.

• Follow JJIM and PSTS procedures to manage programs.

Follow company vendor management SOPs.

Input External Service Provide Oversight Summary.

Initiate outsourcing process, contact CRO for budget proposals and communicate timelines; inform sourcing group to generate contract.

Keep planning and time reporting systems updated.

Approve goods receipt for results and report milestones.

Follow up on sample disposal at the end of the study.

Perform annual reviews of CRO performance in collaboration with BDDS team. Communicate appropriate results with CRO leadership to share successes and resolve critical issues.

• Foster a culture of continuous improvement by proposing innovative ideas and implementing best practices in bioanalysis.

Qualification:

• A Master or above degree (a Ph.D. degree is preferred) in immunology, pharmacology, or other relevant bio-medical science discipline.

• In-depth understanding of modern approaches in BA to support drug development with > 8 years working experience in pharma/biotech/CROs. Experience with clinical trials is preferred.

• Strong expertise in the bioanalytical application of ligand binding assays including immunogenicity assays. Understanding of pharmacokinetics, immunogenicity assays and biomarkers is preferred.

• Demonstrated understanding of the Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidance for bioanalytical method validation and immunogenicity assays is required.

• The ideal candidate will have a successful track record of problem solving, good organizational habits, excellent communication skills in both English and Chinese, the ability to work under timelines, and the ability to collaborate within multidisciplinary teams is required.

• Highly self-motivated and innovative mindset in new BA and related areas.

• Open and honest collaborations with internal and external partners (for example global colleagues, CROs, universities, research institutes).

• Travel percentage – less than 10% of national or international travels.

Required Skills:

Preferred Skills:

Clinical Data Management, Drug Discovery Development, EHS Compliance, Emergency Planning, Performance Measurement, Presentation Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Strategic Thinking, Tactical Planning, Technical Credibility