- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Associate Director of Validation is responsible for leading the ... and company standards for pharmaceutical/radiopharmaceutical production. This role oversees validation activities from initial planning through execution, manages a… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Outline of Role:** Associate Director , Joint Process Team (JPT) is responsible for ... and reports into the Sr. Director - External API Manufacturing Operations. The Associate Director , JPT is the key business relationship owner with the of… more
- Lilly (Lebanon, IN)
- …trial medicines, while also reducing costs and environmental impact. The Associate Director -Automation Engineering - Control System Hardware, I&C, Projects ... of the facility and managing the overall Automation Portfolio and Projects. The Associate Director is also responsible for the productivity and development of… more
- Lilly (Indianapolis, IN)
- …as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical Services/Manufacturing Science (TS/MS) in the ... procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. +… more
- Lilly (Indianapolis, IN)
- …lead the charge in shaping the future of manufacturing at Eli Lilly? As an Associate Director of Engineering, you'll be at the forefront of this exciting ... procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. 4.… more
- Lilly (Lebanon, IN)
- …a successful startup into GMP manufacturing operations._ **Position Description:** The Associate Director - Technical Services/Manufacturing Science (TSMS) is ... responsible for managing the activities of TSMS personnel. The Associate Director TSMS must balance coaching a technical staff, prioritization and staffing for… more
- Lilly (Indianapolis, IN)
- …to support communities through philanthropy and volunteerism. **Responsibilities** **The Associate Director - Technical Services/Manufacturing Science (TS/MS) ... supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical staff, prioritization and staffing for… more
- Lilly (Indianapolis, IN)
- …different site and global IT groups focused on Computer System Validation Strategies, external regulations, industry best practices, policies and procedures ... and within budget. **How You'll Succeed:** + Oversight of computer systems validation strategies and activities across new API facilities, including the review and… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Responsibilities:** The Associate Director - API EM Engineering Leader for Peptides ... processes, and functions. + Direct or indirect experience with commercialization ( Validation , Tech Transfer, CMC, GMP, Quality, and/or HSE) + Demonstrated ability… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug product at CDMOs + Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and… more
- Sumitomo Pharma (Indianapolis, IN)
- …undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with ... Biostatistics to create analysis specifications following the instructions + undefined + Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's + undefined + Perform Data analysis, statistical analysis, generate safety and efficacy… more
- Lilly (Indianapolis, IN)
- …forecast, and manage the end to end global clinical data management, validation , study build, and filing/archiving resources required to deliver all sanctioned ... projects + Drive efficiency and improvement in the Data and Analytics organization + Lead large-scale cross Business Unit/Therapeutic Area projects or programs with high complexity Enterprise Leadership + Represent the Data and Analytics organization at… more
- Lilly (Indianapolis, IN)
- …strong CM relationships to align on goals and expectations. + Lead validation strategy, protocol approval, execution, and reporting. + Manage change controls and ... assess regulatory/process impacts. + Investigate deviations, identify root causes, and implement corrective actions. + Ensure timely process reviews and documentation updates. + Maintain compliant external manufacturing documentation (eg, Quality Agreements,… more
- Lilly (Indianapolis, IN)
- …Parenteral Manufacturing Operations. + Previous Equipment Qualification and Process Validation Experience. + Previous Experience with Manufacturing Execution Systems ... and Electronic Batch Release. + Previous Experience with Deviation and Change Management Systems Including Trackwise. **Other Information:** + Standard business hours (days, M-F) with after-hour support and shutdown support as needed. + Minimal travel… more
- Humana (Indianapolis, IN)
- …Lead Medical Director , depending on the line of business. The Medical Director conducts Utilization Management or clinical validation of the care received by ... of our caring community and help us put health first** The Medical Director actively uses their medical background, experience, and judgement to make determinations… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance (QA) is responsible for managing ... (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Associate Director - QA is primarily responsible for the… more
- Lumen (Indianapolis, IN)
- …the overall product marketing efforts. You will report directly to the Director of Technical Marketing and work closely with other cross-functional teams to ... Architectures: Define deployment architectures that further technical proof and validation . Support customer validation , market segmentation, and competitive… more