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Sr. Scientist, Bioanalytical Deveplopment (Bioassay)

5+ years
$75 - $90 an hour
10 Jan. 23, 2025
Job Description
Job Type: Remote Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Scientist, BioAnalytical Development (Bioassay)
Location: San Francisco (Fully Remote)
Contract Type: Contract
Compensation: $75 - $90 per hour (dependent on experience)


Job Overview:

The Sr. Scientist, BioAnalytical Development (Bioassay) is responsible for overseeing the development, validation, and implementation of pharmacokinetic (PK), immunogenicity, and cell-based assays to support biologic drug candidates in pre-clinical and clinical development. The role requires managing contract research organizations (CROs) and contract manufacturing organizations (CMOs) to develop, validate, and execute bioanalytical and cell-based potency assays. The scientist will be responsible for interpreting and reporting bioanalytical results to support drug discovery and clinical development.

This position collaborates closely with internal departments such as analytical method development/characterization, process development, manufacturing operations, research, development, and quality assurance. The successful candidate will represent the bioanalytical department in cross-functional meetings and provide scientific findings. They will also work with external organizations, including CMOs and contract laboratories, on method transfer, qualification/validation, and implementation of quality control (QC) methods.


Key Responsibilities:

  • Assay Development & Validation:
    Oversee the development, validation, and implementation of PK, immunogenicity, and cell-based assays to measure potency, ensuring compliance with GMP, GLP, and regulatory guidelines.

  • Bioanalytical Testing:
    Execute bioanalytical testing, including PK, immunogenicity, and potency assays, for lot release, stability testing, and product characterization.

  • Collaboration:
    Work closely with internal departments including process development, manufacturing, research, and quality assurance to meet corporate goals and regulatory requirements.

  • CRO & CMO Management:
    Manage CROs and CMOs to develop and execute bioanalytical assays, ensuring timely and accurate results.

  • Reporting & Documentation:
    Interpret and report bioanalytical results to support clinical development and drug discovery activities. Present findings at team meetings.

  • Method Transfer & Qualification:
    Coordinate method transfer, qualification/validation, and implementation of QC methods in collaboration with contract laboratories and CMOs.


Required Skills & Qualifications:

  • Education:

    • Master’s degree in biology, biochemistry, or a related discipline.
    • PhD preferred.
  • Experience:

    • A minimum of 5 years of biotechnology/pharmaceutical industry experience.
    • Hands-on experience with method development, qualification, and validation of cell-based bioassays for potency measurement.
    • Strong knowledge of assay technologies such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc.
  • Technical Skills:

    • Expertise in plate-based and cell-based assay development, execution, and troubleshooting.
    • Proficient in bioanalytical methods for animal and clinical studies.
    • Experience in developing automated sample handling and assay processes is desirable.
    • Knowledge of GLP, GCP, FDA/EMA bioanalytical and immunogenicity guidance, and cGMP environment.
  • Regulatory Knowledge:

    • Familiarity with FDA, ISO, and cGMP requirements for biologics.
    • Experience in drug discovery and the end-to-end CMC regulatory approval process for biologics.
  • Additional Skills:

    • Strong project management experience.
    • Excellent written and verbal communication skills.

Compensation:

  • Hourly Rate: $75 - $90 per hour (based on relevant work experience, skills, and years of experience).

How to Apply:

Interested candidates are invited to submit their updated resume, including relevant work experience, qualifications, and skills.

Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind