Job Description

Responsibilities
• Act as a Subject Matter Expert (SME), leading the design, development, validation, troubleshooting, and implementation of bioanalytical methods (e.g., ELISA, MSD, Gyro, PCR, flow cytometry) for both regulated and non-regulated sample testing, data analysis and study reporting.
• Serve not only as the working scientist but also as the Principal Investigator (PI), providing strategic bioanalytical guidance and consultation for pharmacokinetics, immunogenicity (ADA and Nab), and/or biomarker studies.
• Provide mentorship and scientific/technical/regulatory guidance to junior scientists and collaborators.
• Present and interpret data/results with scientific rigor and regulatory alignment, both internally and externally, ensuring clarity and accuracy.
• Collaborate effectively with clients, ensuring high satisfaction through timely communication, responsive service, and the on-schedule delivery of high-quality results.
• Draft, review, and finalize laboratory data and controlled documents, including bioanalytical study plans and reports.
• Support laboratory operations and collaborate across teams, departments, and sites to improve quality and efficiency
• Collaborate with Business Development to assess client requests and advise on feasibility.
• Represent the team in the development and continuous improvement of policies, procedures, work instructions, and standard operating procedures (SOPs).
• Ensure adherence to internal standards and regulatory requirements, including Code of Conduct, Environmental Health and Safety (EHS), GLP/GCP/GDP/21 CFR Part 11, and relevant guidelines from authority bodies like FDA and EMA.
• Perform additional duties as needed to support team objectives and organizational goals.
• Other tasks as assigned

Skills, Education & Qualifications
• Ph.D. degree in biology or related major, with 10+ years' of working experience in regulated bioanalysis in CRO, biopharmaceutical or biotechnology companies.
• Strong scientific knowledge of bioanalysis on PK, ADA/Nab and biomarker studies using LBA technologies. Knowledge of PCR and flowcytometry technology is a plus.
• Demonstrated experience and expertise in developing/validating/implementing bioanalytical methods for both pre-clinical and clinical programs of various biopharmaceutical modalities (e.g., mAb, BsAb, ADC, fusion protein, nucleic acid, CGT, etc.).
• Extensive knowledge and understanding of regulatory requirements, such as GLP, GDP, GCP, ICH, 21CFR Part 11 and so on.
• Excellent knowledge and understanding of the pharmaceutical industry.
• Extensive experience in managing/conducting studies to support projects.
• Excellent communication skills (writing and speaking).
• Extensive experience in LIMS
• Able to lead, mentor, inspire and develop scientific staff, and to set and lead strategies for growing a group.
• Able to guide trouble shooting for problematic projects (method development, validation and sample analysis) with the team.
• Able to develop and implement research strategies and align with organizational goals.
• Able to foster scientific excellence and build scientific reputation internally and externally.
• Ability to identify opportunities and respond quickly to client requests and expectations.
• Able to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients. Excellent communication, interpersonal, organizational, and multi-tasking skills.

About Us

Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.

We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.

If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.