- Cytel (Springfield, IL)
- …Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to ... **Position Overview:** We are seeking a highly motivated Biostatistician to support CMC projects across the drug development lifecycle. The ideal candidate will have… more
- AbbVie (North Chicago, IL)
- …R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. ... rewarding career opportunities for these candidates. The ideal candidate will have CMC expertise in analytical development for biologics. The candidate will be… more
- AbbVie (North Chicago, IL)
- …expertise for Pipeline products and can represent the company in discussions with regulatory agencies. Due to nature of the projects and support of pipeline and ... significant to AbbVie's pharmaceutical Operations ($1B) to minimize back orders and regulatory risks. + Technical function is responsible for providing support for… more
- AbbVie (North Chicago, IL)
- …Sciences is a global analytical science organization responsible for all CMC analytical activities related to the clinical development and commercialization of ... analytical deliverables are achieved within set timelines, budgets, and regulatory frameworks, while seamlessly integrating analytical and program strategies into… more
- AbbVie (North Chicago, IL)
- …R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. ... and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.… more
- AbbVie (North Chicago, IL)
- …This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery ... the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team. + Effectively and timely communicates study plans, risks and mitigation… more
- AbbVie (North Chicago, IL)
- …and complete results interpretation and reporting. Prepare and review documents for regulatory submissions. + Leading the analytical aspects of a project while ... collaborating with other CMC development functions and other areas in AbbVie to...Proven track record in leading analytical projects within a CMC development team setting. Key Leadership Competencies: + Builds… more
- AbbVie (North Chicago, IL)
- …policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment Responsibilities + Support… more
- AbbVie (North Chicago, IL)
- …. Authors and/or reviews technical reports, manufacturing batch records and regulatory documents concerning Chemistry, Manufacturing and Control ( CMC ) subjects. ... strategies, define project responsibilities and timelines . Author and review key regulatory documents, laboratory data, technical memos and reports. . The position… more
- AbbVie (North Chicago, IL)
- …Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral ... and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.… more