- Merck (Rahway, NJ)
- …GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation Biologics (NGB) facility at our ... 3-4 exempt and non-exempt employees to support bulk clinical manufacturing of biologic drug substances, and at times will require hands-on approach on the processing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety ... Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies. + Oversees and guides Company Core Data… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. The Senior Director of HSE Global Manufacturing provides leadership, direction, and oversight of the ... Health, Safety and Environmental (HSE) management system for Lilly Manufacturing...+ In close partnership with the Corporate HSE Senior Director , provide external view of trends and best practices… more
- Charles River Laboratories (Rockville, MD)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and...services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their… more
- AbbVie (North Chicago, IL)
- …is aligned closely with the clinical/regulatory development strategy and provides drug development experience and advice to the CMC team. Influences development ... author responses to questions from regulatory authorities. + Leverage extensive biologics drug development experience to lead the global cross-functional CMC Team in… more
- Lilly (Indianapolis, IN)
- …across manufacturing. **Responsibilities:** + Lead team to maintain a strong safety culture. + Develop and deliver standardized robotics solutions across ... and professional and technical growth for employees. + Be a champion for safety activities and a role model for diversity, ethics, and compliance. + Complete… more
- Lilly (Indianapolis, IN)
- …and standards. + Escalate supply risks, major deviations, and safety /cybersecurity concerns. + Implement process improvements, control strategies, and regulatory ... and external technical/quality networks. + Strong understanding of cGMPs and drug product manufacturing. + Excellent communication skills, with attention to detail… more
- AbbVie (North Chicago, IL)
- …integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be… more
- Lilly (Indianapolis, IN)
- …3-6 month horizon. + **Lead by example** and **coach** others in safety , quality, engineering, and continuous improvement. + **Interact** directly with regulatory ... pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (eg, healthcare and/or dependent day care… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …genetics studies to aid in the selection of indications or evaluation of safety considerations. + Participate in the intellectual life of the Cardiometabolic TAG, ... scores, quantitative traits analyses and Mendelian randomization. + Understanding of drug development and clinical trial design and execution. Experience as… more