Scientist III- LC/MS at BioAgilytix

Durham, North Carolina, United States

BioAgilytix Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries

Requirements

  • Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment
  • Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays
  • Demonstrated expertise in developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies by extracting analytes
  • Strong background in method development, GxP-compliant validation, and targeted and untargeted analysis using chromatography and mass spectrometric platforms

Responsibilities

  • Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies including project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management
  • Act as primary client contact, presenting data, ensuring clear communication, and aligning project deliverables with client timelines and expectations
  • Lead assay development, validation, and sample analysis of biologics, proteins, peptides, ADCs, and/or biomarkers using chromatographic and mass spectrometric (LC/MS) techniques in support of preclinical, clinical, and product release studies
  • Design, plan, and execute experiments independently; troubleshoot assays; analyze and interpret data; prepare summary tables, plans, reports, and SOPs
  • Ensure GLP compliance throughout assay development, validation, and sample analysis activities, including prompt identification and notification of deviations and preparation of associated documentation
  • Set up and manage studies in LIMS; maintain accurate laboratory records, worksheets, and raw data with peer review
  • Train, mentor, and direct junior scientists and analysts, including preparing and reviewing scientific training materials
  • Provide scientific leadership by planning experimental designs for junior staff and driving bioanalytical projects to successful completion
  • Other duties as needed

Skills

LC/MS
Liquid Chromatography
Mass Spectrometry
Method Development
GxP Validation
Bioanalytical Analysis
Project Management
Proposal Preparation

BioAgilytix

Bioanalytical testing for drug development

About BioAgilytix

BioAgilytix offers specialized bioanalytical testing services for the pharmaceutical, biotechnology, and agricultural biotechnology industries, focusing on large molecule studies essential for drug development. They provide various assays, including pharmacokinetics, pharmacodynamics, cell-based, and immunogenicity assays, to measure drug effects and safety. With a global presence, particularly in Europe, BioAgilytix distinguishes itself by its comprehensive testing services tailored to the needs of life sciences companies. Their goal is to support the development and validation of new treatments while ensuring the safety and efficacy of agricultural products.

Durham, North CarolinaHeadquarters
2008Year Founded
$29.3MTotal Funding
GROWTH_EQUITY_VCCompany Stage
Biotechnology, HealthcareIndustries
501-1,000Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Paid Vacation
Paid Sick Leave
Paid Holidays
401(k) Company Match
Parental Leave
Employee Referral Bonus

Risks

Cancellation of Durham expansion may impact growth and local economic contributions.
Regulatory challenges may arise in US market for Stockholm3 prostate cancer test.
Hamburg lab expansion may strain resources, affecting service quality.

Differentiation

Specializes in immunoassays and cell-based assays for large molecule studies.
Operates globally with significant presence in Europe and the US.
Offers comprehensive suite of assays including PK, PD, and immunogenicity.

Upsides

Increased demand for personalized medicine boosts need for specialized testing services.
Growing market for biosimilars and biobetters expands client base opportunities.
Global cell-based assay market growth aligns with BioAgilytix's expertise.

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