Sr. Scientist, BioAnalytical Deveplopment (Bioassay)

Integrated Resources, Inc ( IRI ); United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Sr. Scientist in BioAnalytical Development to lead the development and validation of critical assays for drug candidates. This fully remote role involves managing CROs and CMOs while collaborating with various internal departments to achieve corporate goals. The ideal candidate will have extensive experience in biological assay development, particularly with ELISA and cell-based assays, and a solid understanding of regulatory processes. Join a forward-thinking organization where your expertise will directly impact drug discovery and clinical development activities.

Qualifications

• 5+ years in biotechnology/pharmaceutical industry required.
• Proficient in assay development, validation, and regulatory processes.

Responsibilities

• Oversee the development and validation of bioanalytical assays.
• Collaborate with cross-functional teams and external organizations.

Skills

Biological assay development

ELISA

Cell-based assay development

Quality Control execution

Method development/qualification/validation

Regulatory drug approval process

Automated sample handling

cGMP knowledge

GLP and GCP knowledge

Education

Master’s degree in biology/biochemistry

PhD in relevant field

Job description

Sr. Scientist, BioAnalytical Development (Bioassay)

The ideal candidate is responsible for overseeing the development, validation, and implementation of PK, immunogenicity, and cell-based assays in both the regulated and non-regulated environment to support Client biologics drug candidates in pre-clinical and clinical development. This is a fully remote position with the candidate responsible for managing CROs and CMOs to develop, validate, and execute bioanalytical and cell-based potency assays, and for interpreting and reporting bioanalytical results to support drug discovery and clinical development activities.

This position will collaborate closely with internal cross-functional departments, including analytical method development/characterization, process development, manufacturing operations, research, development, and quality assurance, to achieve corporate goals and objectives. The individual will represent the bioanalytical department in cross-functional discussions and present scientific findings at team meetings. This position will also require working closely with multiple external contract organizations including CMOs and Contract Laboratories in the areas of method transfer, qualification/validation and implementation of QC methods, with focus on plate-based and cell-based assays, including PK, immunogenicity, potency methods for lot release, and stability studies.

The successful candidate must be proficient in biological assay development (ELISA and cell-based) and be proficient in Quality Control execution and systems, stability study programs, method development/qualification/validation, and end to end CMC regulatory drug approval process for biologic drug substances and drug products.

Education:

A minimum of a Master’s degree in a biology/biochemistry discipline is required. Advanced degree such as PhD is preferred. A minimum of 5 years previous biotechnology/pharmaceutical industry experience is required.

Skills:

Must have in-depth knowledge and hands-on experience in plate-based and cell-based assay development, execution and troubleshooting, as well as expert knowledge of methods and immunoassay technologies, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc. to support animal and clinical studies. Experience with developing automated sample handling and assay processes is desirable. Knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is desirable.

A thorough knowledge and experience working in a cGMP environment is desirable. A thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities and project management experience is a plus.

Minimum Degree Required:

Master's Degree

Schedule:

Start Date: 01/02/2025

End Date: 12/31/2025

Days Per Week: 5.00

Seniority level:

Mid-Senior level

Employment type:

Contract

Job function:

Research

Industries:

Pharmaceutical Manufacturing and Biotechnology Research