- Lilly (Indianapolis, IN)
- …of drug product and radioisotopes. + Participate in technical transfer and process validation activities in collaboration with other departments. + Safely ... Control to resolve quality events and support on-time product release + Support process development, technical transfer, and validation activities for new or… more
- Lilly (Indianapolis, IN)
- …American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations ... launch new products/ packages/ CMs + Participate on Joint Process Teams + Understand Lily global quality systems and...metrics for trends at the CM + Support Qualifications/ Validation document creation and reviews + Provide and coordinate… more
- Lilly (Indianapolis, IN)
- …Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide ... the world! **Organization Overview:** Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a… more
- Lilly (Indianapolis, IN)
- …and changes, approval of date extension requests and due date changes, approval of process validation protocols and reports, approval of validation master ... of risk-based rationale if bracketing of products is used for cleaning validation , etc.) + Ensure adequate quality oversight for manufacturing operations within… more
- Novo Nordisk (Bloomington, IN)
- …is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product ... 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee… more
- Novo Nordisk (Bloomington, IN)
- …is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product ... 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee… more
- Lilly (Lebanon, IN)
- … variability and capability. + Understand, justify and document the state of validation ( process and cleaning) with data that evaluate the capability of ... manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and… more
- Lilly (Indianapolis, IN)
- …activities of QA personnel supporting the oversight of Insulin Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical ... global regulatory manufacturing guidance, and the corporate/industry standards for validation . The position requires working cross-functionally within the site,… more
- Lilly (Indianapolis, IN)
- …to develop, investigate, optimize, and validate analytical methods within pharmaceutical manufacturing. Provide analytical support, project leadership, and technical ... with developing, investigating, optimizing, and validating analytical methods within pharmaceutical manufacturing. Experience must include a minimum of: 3 years… more
- Novo Nordisk (Bloomington, IN)
- …of agreements + Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (eg, PPQ, CPV, APR / ... is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product… more
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