- 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
- Lilly (Indianapolis, IN)
- …Lilly and Active Pharmaceutical Ingredient (API) Contract Manufacturer representatives. The JPT Associate Director is the key business relationship owner and is ... materials are delivered on time and within downstream customer expectations. The JPT Associate Director will partner with Lilly's Process Research & Development… more
- Lilly (Indianapolis, IN)
- …world. Eli Lilly and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, ... peptide processes from development to manufacturing, ensuring successful scale-up, validation , and regulatory compliance. * Design, execute, and interpret… 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
- 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
- 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
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Job Description** The Assoc. Director , IT Regulatory, Clinical and Enterprise Systems is an integral part of ... patients in need. In this role, you will report directly to the Exec. Director , IT and be primarily responsible for implementing RayzeBio's vision for growth and… more
- Lilly (Indianapolis, IN)
- …with CMs to ensure alignment of intents and objectives. + Validation : ensure proper definition of strategies, revisions, protocol approvals, validation ... External Manufacturing documentation (eg, Quality Agreements, Manufacturing Requirements Document, validation documents) is in place and in compliance. + Build… more
- Merck (Indianapolis, IN)
- …Under the guidance of dCMC Regulatory Authoring Leadership, the Associate Principal Scientist, Regulatory Authoring Business Owner, will optimize regulatory ... analytical development or commercialization, with knowledge of method development, validation , specification setting and justification. + Practical knowledge of… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …Profound grasp of Machine Learning lifecycle - feature engineering, training, validation , scaling, deployment, scoring, monitoring, and feedback loop. + Have ... implemented machine learning projects from initiation through completion with particular focus on automated deployment and ensuring optimized performance. + Agile skills and experience + Experience in Healthcare (esp. US) industry is a plus. **Competencies**… more
- GRAIL (Indianapolis, IN)
- …and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change ... control processes. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in… more
- Lilly (Indianapolis, IN)
- …teams). + Mechanical aptitude (knowledge of mechanical equipment, controls, and validation for medical devices). + Knowledge of manufacturing (preferably discrete ... manufacturing). + Understanding of GMP and ISO requirements for drug delivery devices. + Familiarity with analytical test systems and test method requirements for drug delivery devices. **Additional Preferences** + Understanding of statistics and design of… 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
- 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
- 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
- Veterans Affairs, Veterans Health Administration (Marion, IN)
- …that associate degree/entry level requires a formal degree equivalency validation from a recognized equivalency evaluation accepted by VA such as International ... career opportunity available for a Registered Nurse Whole Health Clinical Director to provide vision, planning, management, and coordination for the implementation… more
- Lilly (Indianapolis, IN)
- …and documenting and maintaining the state of process/sterility assurance/cleaning validation . **Key Objectives / Deliverables:** + Responsible for maintaining a ... initiatives for staff + Communicate effectively with Parenteral TS/MS Network Director and other Parenteral TS/MS leaders to ensure alignment of technical… more
- Lilly (Indianapolis, IN)
- …Understand product history and potential failures modes for the process and the associate countermeasures + Generate, review, revise, and maintain as needed all the ... manufacturing and validation documentation (eg...properly and in a timely manner to TS/MS Sr. Director about project status, issues, etc. Identifying issues root… more