- Novo Nordisk (Bloomington, IN)
- …facility + Drives compliance with all applicable corporate and regulatory SOP and cGMP guidelines for their area of responsibility + Leads team members to improve ... data integrity and ensure compliance with company SOP's, specifications, as well as cGMP , ICH, FDA, EMA regulations or guidelines + Able to combine and interpret… more
- Lilly (Lebanon, IN)
- …or formal discussion (crew meetings, safety representative). + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and ... a pharmaceutical manufacturing operation. + Solid understanding of FDA guidelines and cGMP requirements. + Strong organizational skills and ability to handle and… more
- Lilly (Lebanon, IN)
- …or formal discussion (shift meetings, safety representative). + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and ... priorities without direct supervision + Solid understanding of FDA guidelines and cGMP requirements + Strong organizational skills and ability to handle and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …recommending and implementing innovations where appropriate + Ensure compliance with cGMP regulations and other relevant quality standards + Represent the MSAT ... scale-up, and technology transfer of biologics products + Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing + Experience… more
- Lilly (Lebanon, IN)
- …IT capability. + Compliance + Provide leadership in the development and execution of cGMP and/or improvement plans within the IT function and in support of site ... cGMP improvement plans. + Define and execute IT inspection readiness activities. + Operational Excellence + Ensure IT organization is functionally strong and… more
- Lilly (Indianapolis, IN)
- …knowledge of bioconjugation principles and development/purification methods. + Basic understanding of cGMP principles and previous oversight of cGMP processes. + ... Demonstrated control strategy development capabilities (eg nitrosamine, conjugatable impurities). + Demonstrated registration stability, process validation, or post-approval process development leadership. + Track record of personnel mentorship and development… more
- Novo Nordisk (Bloomington, IN)
- …other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments + Apply advanced knowledge of ... to use Excel, Word, and other office systems + Strong understanding of cGMP regulations, FDA guidelines, and industry standards related to clean utilities, sterile… more
- Lilly (Indianapolis, IN)
- …conversations, etc. + Collaborate with Site Quality to ensurecompliance with cGMP /cGLPQuality equipment cleaning requirements including, but not limited to: + ... field (advanced degree preferred) + 10+ years of experience in a cGMP large-scale pharmaceutical manufacturing facility. + Technical knowledge of cleaning equipment… more
- Lilly (Indianapolis, IN)
- …processes from development labs to the pilot plant to enable translation to cGMP production of kilogram quantities of API to supply clinical trials. The Chemist ... + 10+ years of experience with small molecule processing in a cGMP environment. **Additional Skills and Preferences** + Supervisory experience, ideally of small… more
- CBRE (Indianapolis, IN)
- …and various development laboratories. Portions of these facilities fall under cGMP requirements, and this position will support critical facilities and systems ... specifically associated with cGMP operations **What you'll do** + Facilities and utilities regulatory compliance (FUME) is critical for effective operation of… more