Principal Research Scientist II - Analytical Development
AbbVie
August 29, 2026
Remote friendly (Waltham, MA)
United States
$141,500 - $268,500 USD yearly
Clinical Research and Development
Responsibilities:
- Lead and mentor scientists on separation-based assays (HPLC, capillary electrophoresis) for sample testing supporting biologics (mAbs and drug substance) development, characterization, validation, and GMP manufacturing investigations.
- Act as process analytics lead for mab and DS in CMC teams; partner with process development; balance stakeholder needs to ensure collaboration.
- Serve as subject-matter expert for separation-based methods, including development, execution, and troubleshooting.
- Evaluate/select analytical technologies; support automation and high-throughput method development to deliver high-quality testing results.
- Author/review analytical sections of IND/BLA submissions; support responses to agency information requests; ensure regulatory compliance.
- Collaborate on program transition and analytical strategy alignment; guide peers on project management and separation-technique skills.
- Communicate strategies, issues, and risks; promote proactive risk resolution.
Qualifications:
- PhD (chemistry, biology, biochemistry, chemical engineering, or related). 8+ years biotech/pharma experience.
- Proven leadership of analytical development for late-stage biologics (mAbs, multispecifics, ADCs, fusion proteins).
- Expertise in protein/impurity analysis (HPLC, capillary electrophoresis); mass spectrometry and ELISA a plus.
- Strong technical writing for regulatory submissions and agency responses.
- People leadership; excellent communication/interpersonal skills; cross-functional collaboration.
- Strong troubleshooting/problem-solving, attention to detail, ability to manage multiple complex projects.
Benefits (if applicable): paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
- Lead and mentor scientists on separation-based assays (HPLC, capillary electrophoresis) for sample testing supporting biologics (mAbs and drug substance) development, characterization, validation, and GMP manufacturing investigations.
- Act as process analytics lead for mab and DS in CMC teams; partner with process development; balance stakeholder needs to ensure collaboration.
- Serve as subject-matter expert for separation-based methods, including development, execution, and troubleshooting.
- Evaluate/select analytical technologies; support automation and high-throughput method development to deliver high-quality testing results.
- Author/review analytical sections of IND/BLA submissions; support responses to agency information requests; ensure regulatory compliance.
- Collaborate on program transition and analytical strategy alignment; guide peers on project management and separation-technique skills.
- Communicate strategies, issues, and risks; promote proactive risk resolution.
Qualifications:
- PhD (chemistry, biology, biochemistry, chemical engineering, or related). 8+ years biotech/pharma experience.
- Proven leadership of analytical development for late-stage biologics (mAbs, multispecifics, ADCs, fusion proteins).
- Expertise in protein/impurity analysis (HPLC, capillary electrophoresis); mass spectrometry and ELISA a plus.
- Strong technical writing for regulatory submissions and agency responses.
- People leadership; excellent communication/interpersonal skills; cross-functional collaboration.
- Strong troubleshooting/problem-solving, attention to detail, ability to manage multiple complex projects.
Benefits (if applicable): paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.