- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... life-changing new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - … more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This ... and Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- Lilly (Indianapolis, IN)
- …The Associate Director , CMC Project Management may also partner with the Senior Director or Assoc. VP, CMC Project Management to deliver high ... P2 in the new role. **Position Summary:** The Associate Director , CMC Project Management will provide strategic...and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional… more
- Lilly (Indianapolis, IN)
- …development cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected ... life better for people around the world. The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
- Lilly (Indianapolis, IN)
- …+ Partner with cross-functional teams to ensure seamless integration of CMC development activities with other areas including discovery, toxicology, ... **Role Overview:** We are seeking a veteran and visionary Sr . Director of Early Phase Chemistry to...of equivalent work experience. + Minimum 10 years of CMC experience, specifically in early phase drug development… more
- Lilly (Lebanon, IN)
- …clinical trial medicines, while also reducing costs and environmental impact. The Senior Director , Process Translation and Execution is directly responsible for ... hybrid and biologics operations with onsite lab capabilities. The Senior Director Process Translation & Execution will...site and for potential assignments across Product Research & Development ( CMC ) and manufacturing. + Works closely… more
- Lilly (Indianapolis, IN)
- …people around the world. **Organizational Overview:** The Synthetic Molecule Design and Development (SMDD) team is involved in key activities for the development ... expertise to accelerate testing of the clinical hypothesis and overall drug development . SMDD delivers on these responsibilities by recognizing diverse talent and… more
- Lilly (Indianapolis, IN)
- …sites or internally at Lilly manufacturing facilities. The Senior /Executive Director is accountable for the development , oversight and management of ... and operational oversight for the raw materials and components applied in CMC development and clinical trial material production. **Operational Excellence,… more
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