Senior Scientist I, Analytical Development Documentation Specialist
5 days ago
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
As a Senior Scientist I in our Analytical Development Documentation team, you will play a critical role in supporting the development and commercialization of AbbVie's parenteral products. Your expertise in analytical method development, cGMPs, and international pharmaceutical guidelines will be essential in ensuring the quality and integrity of our products.
Key Responsibilities- Provide support to Analytical Leads and Lab Managers across multiple projects, including creating, reviewing, and verifying specification reports, stability study protocols, and technical reports.
- Perform change management for document updates and review/verify IND/IMPD/BLA sections using source documents provided by the Analytical Leads and Lab Managers.
- Assist with compiling information for special requests from health authorities, such as chromatographic overlays and data needed for responding to questions.
- PhD (0+ years), Master's Degree (8+ years), or Bachelor's Degree (10+ years) in a scientific discipline, such as Analytical Chemistry, Biochemistry, or Biology.
- Strong scientific writing skills and verbal communication skills.
- Ability to manage and prioritize multiple projects simultaneously and work within timelines.
- Knowledge and experience in analytical method development, with exposure to cGMPs, international pharmaceutical guidelines, and the CMC content of regulatory submissions.
- Experience documenting and reviewing laboratory notebooks in compliance with Good Laboratory/Manufacturing Practices.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs. AbbVie is committed to providing a work environment that is free from discrimination and harassment. We are an equal opportunity employer and welcome applications from diverse candidates.
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