Purpose

InnoAlliance is a Contract Research Organization (CRO) providing top tier quality bioanalytical services. We aim to partner with all companies that need bioanalytical support, from multinational pharmaceuticals to mid- and small-size biotech companies including startups and virtual companies. Our service areas range from standard biomarker testing to customized PK/ADA method development and validation. We are looking for an experienced scientist/senior scientist to join our passionate team to partner with our clients for success.

Role and Responsibilities

Lead effort in developing, validating, and performing unique bioanalytical methods according to the demands.

Perform sensitive, reliable and efficient bioanalytical assays, data analysis, data QC, and data interpretation. Oversee the execution of all work to ensure operational team is meeting study compliance for all work performed.

Maintain schedule of projects and timelines. Effectively handle multiple projects, including communication with the clients on regular basis.

Maintain basic instruments, computer programs, and SOPs required for studies. Maintain and support safe lab practices and environment.

Perform system validation for major bioanalytical instruments with some technical support.

Help with training and/or mentoring of junior scientific staff. Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities.

Act as the subject matter expert on ligand-binding assay development and validation. Additional molecular and cell-based assay support is a plus. 

Ph.D. or Master’s degree in biology, immunology, chemistry, biomedical engineering, or related scientific fields required with a minimum of 5 years' relevant industrial experience.

Demonstrated expertise in bioanalytical assays including PK, ADA, and biomarker testing. Proven experience in ligand binding assays.

Familiar with current regulatory guidance and industry best practice. Hands on experience working under GLP, GMP or GCLP environments. Familiar with GMP/GLP regulations and ICH guidelines.

Great leadership experience in both project and people management is required.

Excellent communication, interpersonal, organizational, and multi-tasking skills. Bilingual skills (English and Mandarin) required, both speaking and writing,due to the nature of working closely with Chinese counterparts.

Ability to work independently and pay good attention to the details.