Principal Research Scientist II - Analytical Development

About the role

The Principal Research Scientist II will be an integral part of the Analytical Development team in the Operations – Product Development Science and Technology – Biologics division. The role involves supporting analytical aspects of biologics products with a focus on advancing AbbVie’s late-stage clinical programs. This position calls for an individual with a strong technical analytical background, demonstrated leadership skills, and the ability to effectively communicate and work cross-functionally.

Responsibilities

- Lead and mentor scientists specializing in separation-based assays including HPLC and capillary electrophoresis for sample testing to support biologics mab and DS process development, characterization, validation as well as GMP manufacturing investigation activities. - Serve as the process analytics lead for mab and DS in AbbVie’s CMC teams, supporting late-stage biologics pipeline assets. Act as a partner to the process development groups. Balance stakeholder expectations to ensure effective collaboration. - Serve as the subject matter expert for separation-based methods, providing expertise and support for method development, execution, and troubleshooting. - Evaluate and select effective analytical technologies and methods to meet program needs. Support automation and development of high-throughput analytical methods and drive timely delivery of high-quality testing results. - Participate in the preparation and review of technical documents for late-stage programs. Author and review analytical sections of IND/BLA filings, provide response support to agency information requests. Ensure all submissions comply with regulatory requirements and industry standards. - Collaborate with other analytical teams in R&D and PDS&T on program transition, workflow and program strategic alignment. Provide guidance to peers on project management, analytical strategy development, and technical skills related to separation techniques. - Communicate project strategies, issues, and risks to relevant teams. Promote proactive risk resolution within and across functional areas to advance project objectives. - Demonstrate scientific excellence, advance science and innovation. Implement novel analytical techniques to enhance method robustness and expand analytical capabilities.

Requirements

- PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline. Minimum of 8+ years (PhD) of professional experience working in biotech/pharmaceutical setting. - Proven experience managing and leading analytical development activities for late-stage biologic development, including mAbs, multi-specifics, antibody-drug conjugates, and fusion proteins. - Expertise in protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and other relevant methods. Experience with mass spectrometry and ELISA is a plus. - Skilled in technical writing including experience in authoring, reviewing regulatory submissions and responding to agency information requests. - Strong people leadership skills and demonstrated ability to foster an engaging, inclusive and collaborative team environment. - Excellent communication and interpersonal skills, effectively managing relationships to enhance team decision-making. - Ability to work effectively across functions, anticipating and addressing overall program development needs. - Ability to quickly comprehend and adapt to new situations, with an open mindset and can-do attitude, demonstrating agility where necessary to address evolving project needs. - Ability to think critically and demonstrate troubleshooting and problem-solving skills. High attention to detail. - Ability to lead and manage multiple projects of significant scope and complexity, while meeting all deliverables and timelines. - An independent, self-motivated, proactive individual who thrives in a fast-paced team environment.

Qualifications

- Bachelor's degree in chemistry, biology, biochemistry, chemical engineering, or related technical discipline. - Minimum of 5+ years (BS) of professional experience working in biotech/pharmaceutical setting. - Demonstrated experience in analytical development and method development. - Basic understanding of protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and other relevant methods. - Familiarity with technical writing and regulatory submission processes. - Good interpersonal and communication skills. - Ability to work effectively across functions and adapt to new situations. - Ability to think critically and solve problems. - Attention to detail. - Ability to manage multiple projects and meet deadlines.

Skills

- Strong analytical skills and knowledge of separation-based assays including HPLC and capillary electrophoresis. - Proficiency in protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and mass spectrometry. - Excellent technical writing and regulatory submission skills. - Strong leadership and mentoring abilities. - Effective communication and interpersonal skills. - Ability to work effectively across functions and adapt to new situations. - Critical thinking and problem-solving skills. - Attention to detail. - Project management and time management skills.

Benefits

- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). - Participation in long-term incentive programs. - Equal opportunity employer. - Reasonable accommodations available for qualified individuals with disabilities.

Pay

$141,500 - $268,500 USD