Principal Research Scientist II - Analytical Development
AbbVie
June 26, 2026
Remote friendly (Waltham, MA)
United States
$141,500 - $268,500 USD yearly
Operations
Principal Scientist II (Analytical Development, Biologics)
Responsibilities:
- Lead and mentor scientists specializing in separation-based assays (HPLC, capillary electrophoresis) for biologics mab/DS sample testing supporting process development, characterization, validation, and GMP manufacturing investigations.
- Serve as process analytics lead for mab and DS in CMC teams; partner with process development groups and balance stakeholder expectations.
- Act as subject matter expert for separation-based methods (development, execution, troubleshooting).
- Evaluate and select analytical technologies/methods; support automation and high-throughput method development to deliver high-quality testing results.
- Prepare and review technical documents for late-stage programs; author/review analytical sections of IND/BLA filings and support agency information requests to ensure regulatory compliance.
- Collaborate with R&D and PDS&T analytical teams on program transition and strategy; guide peers on analytical strategy and separation techniques.
- Communicate project strategies, issues, and risks; promote proactive risk resolution.
- Implement novel analytical techniques to enhance robustness and expand capabilities.
Qualifications:
- PhD in chemistry/biology/biochemistry/chemical engineering or related field; 8+ years biotech/pharma experience.
- Experience leading analytical development for late-stage biologics (mAbs, multi-specifics, ADCs, fusion proteins).
- Expertise in protein/impurity analysis (HPLC, capillary electrophoresis); mass spectrometry and ELISA a plus.
- Technical writing experience for regulatory submissions and agency responses.
- Strong people leadership and communication; cross-functional collaboration.
- Critical thinking, troubleshooting, high attention to detail.
- Ability to manage multiple complex projects and meet timelines.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.
Responsibilities:
- Lead and mentor scientists specializing in separation-based assays (HPLC, capillary electrophoresis) for biologics mab/DS sample testing supporting process development, characterization, validation, and GMP manufacturing investigations.
- Serve as process analytics lead for mab and DS in CMC teams; partner with process development groups and balance stakeholder expectations.
- Act as subject matter expert for separation-based methods (development, execution, troubleshooting).
- Evaluate and select analytical technologies/methods; support automation and high-throughput method development to deliver high-quality testing results.
- Prepare and review technical documents for late-stage programs; author/review analytical sections of IND/BLA filings and support agency information requests to ensure regulatory compliance.
- Collaborate with R&D and PDS&T analytical teams on program transition and strategy; guide peers on analytical strategy and separation techniques.
- Communicate project strategies, issues, and risks; promote proactive risk resolution.
- Implement novel analytical techniques to enhance robustness and expand capabilities.
Qualifications:
- PhD in chemistry/biology/biochemistry/chemical engineering or related field; 8+ years biotech/pharma experience.
- Experience leading analytical development for late-stage biologics (mAbs, multi-specifics, ADCs, fusion proteins).
- Expertise in protein/impurity analysis (HPLC, capillary electrophoresis); mass spectrometry and ELISA a plus.
- Technical writing experience for regulatory submissions and agency responses.
- Strong people leadership and communication; cross-functional collaboration.
- Critical thinking, troubleshooting, high attention to detail.
- Ability to manage multiple complex projects and meet timelines.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.