Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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.
Additional Information
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 employee 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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