Principal Research Scientist II - Analytical Development

AbbVie; Waltham (MA); Sur place; USD 141 500 - 268 500; Plein temps

Avantages offerts par ce poste

Paid time off

Medical, dental, and vision insurance

401(k) plan

Long-term incentive programs

Résumé du poste

AbbVie, based in Waltham, Massachusetts, is seeking a Principal Research Scientist II for the Analytical Development team. This role supports analytics for biologics products and requires expertise in HPLC and capillary electrophoresis.

The successful candidate will lead a team, manage projects, and ensure collaboration across functions. A PhD and solid experience in biotech are essential for this position, which offers a competitive salary range of $141,500 to $268,500 annually.

Qualifications

• 8+ years of professional experience in biotech/pharmaceutical setting.
• Proven experience managing analytical development for biologic products.
• Skilled in technical writing and regulatory submissions.

Responsabilités

• Lead and mentor scientists in analytical methods for biologics.
• Serve as process analytics lead in CMC teams for late-stage projects.
• Develop and execute high-throughput analytical methods.

Connaissances

Leadership skills

HPLC

Capillary electrophoresis

Mass spectrometry

ELISA

Technical writing

Interpersonal skills

Problem-solving skills

Attention to detail

Formation

PhD in chemistry, biology, biochemistry, chemical engineering or related discipline

Description du poste

Principal Research Scientist II - Analytical Development

• Full-time
• Salary Min: 141500
• Salary Max: 268500
• Workday Global Grade: 20
• Compensation: USD 141,500 - USD 268,500 - yearly

The Principal 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 standard.
• 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.

Qualifications

• 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long‑term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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