Principal Research Scientist II - Analytical Development
AbbVie
August 08, 2026
Remote friendly (Waltham, MA)
United States
$141,500 - $268,500 USD yearly
Clinical Research and Development
The Principal Scientist II will be an integral part of the Analytical Development team in Operations – Product Development Science and Technology – Biologics. The role supports analytical aspects of biologics products for late-stage clinical programs, requiring strong technical analytical expertise, leadership, and cross-functional communication.
Responsibilities:
- Lead and mentor scientists specializing in separation-based assays (HPLC, capillary electrophoresis) for biologics (mab and DS) process development, characterization, validation, and GMP manufacturing investigations.
- Serve as process analytics lead for mab and DS in CMC teams; partner with process development to balance stakeholder expectations and ensure effective collaboration.
- Act as subject matter expert for separation-based methods across development, execution, and troubleshooting.
- Evaluate and select analytical technologies/methods; support automation and development of high-throughput methods to deliver timely, high-quality results.
- Prepare and review technical documents; author/review IND/BLA analytical sections and support agency information requests to ensure regulatory compliance.
- Collaborate on program transition and analytical strategy alignment; guide peers on project management and separation-technique skills.
- 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; 8+ years biotech/pharma experience.
- Proven leadership in 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.
- Strong technical writing for regulatory submissions and agency responses.
- People leadership and inclusive, collaborative team-building.
- Excellent communication/interpersonal skills; cross-functional effectiveness.
- Strong troubleshooting/problem-solving, attention to detail.
- Ability to manage multiple complex projects and meet timelines.
- Independent, proactive, fast-paced environment.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); long-term incentive program eligibility.
Responsibilities:
- Lead and mentor scientists specializing in separation-based assays (HPLC, capillary electrophoresis) for biologics (mab and DS) process development, characterization, validation, and GMP manufacturing investigations.
- Serve as process analytics lead for mab and DS in CMC teams; partner with process development to balance stakeholder expectations and ensure effective collaboration.
- Act as subject matter expert for separation-based methods across development, execution, and troubleshooting.
- Evaluate and select analytical technologies/methods; support automation and development of high-throughput methods to deliver timely, high-quality results.
- Prepare and review technical documents; author/review IND/BLA analytical sections and support agency information requests to ensure regulatory compliance.
- Collaborate on program transition and analytical strategy alignment; guide peers on project management and separation-technique skills.
- 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; 8+ years biotech/pharma experience.
- Proven leadership in 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.
- Strong technical writing for regulatory submissions and agency responses.
- People leadership and inclusive, collaborative team-building.
- Excellent communication/interpersonal skills; cross-functional effectiveness.
- Strong troubleshooting/problem-solving, attention to detail.
- Ability to manage multiple complex projects and meet timelines.
- Independent, proactive, fast-paced environment.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); long-term incentive program eligibility.