- AbbVie (Irvine, CA)
- …screening and characterization (surface tension assessment and pyrene-based fluorescence CMC determination) + Exposing protein formulations to stress (expose the ... formulation to manufacture and storage-related stresses) + Characterization of parenteral liquids and lyophilizates using state-of-the-art methods + Protein stability evaluation + Actively interact with the DPD team members, generate high-quality data based on… more
- Parexel (Salt Lake City, UT)
- …BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified ... and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their… more
- Jacobs (Fort Lauderdale, FL)
- …delivery strategies - traditional design-bid-build or CM-atRisk (CMAR) or CM-as-Constructor ( CMc ) or Engineer-Procure-Construct (EPC) or Design Build (DB) - the ... Business Leader provides project execution expertise through team leadership (project managers and/or construction managers), technical acumen, financial, schedule and quality control, commercial and risk management to meet project and Company objectives. The… more
- Lilly (Indianapolis, IN)
- …or advance drug development and manufacturing + Author/review sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for successful ... product approval throughout the world + Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, multivariate analysis, Bayesian methods, quality by design, and more. Communication of… more
- AbbVie (South San Francisco, CA)
- …The team is responsible for all Chemistry, Manufacturing, and Control ( CMC ) cell line and bioprocess development activities for AbbVie's early-stage products. ... The BioCMC Developmental Sciences Intern will have the opportunity to learn and work on key aspects of developing fundamental scientific understanding related to AbbVie's projects and processes, including exposure to innovative projects applying advanced gene… more
- Lilly (Indianapolis, IN)
- …procedures, data requirements and summaries. + Author technical reports and CMC related documents including sections in regulatory submission documents (eg, IND, ... IMPD, BLA). + Publish original research externally, travel to conferences to share and learn about the external environment and latest trends and technologies, leveraging those learnings on novel Lilly medicines. + Design and execute laboratory experimentation… more
- AbbVie (South San Francisco, CA)
- …solutions. We are responsible for all Chemistry, Manufacturing, and Control ( CMC ) analytical activities related to the development of AbbVie's products. The ... intern will have the opportunity to learn and work on key aspects of developing our fundamental scientific understanding as it relates to AbbVie projects and processes. Key responsibilities include: + Develop chromatography, electrophoresis, mass spectrometry,… more
- GE Aerospace (West Chester, OH)
- …organization and CES FP&A to ensure alignment across the organization. Own CMC Nozzle scrap allocation process, ensuring compliance and accuracy. + Independently ... perform analytics to identify opportunities and risk. Finding new ways to look at data, then use the findings to drive action. Run analytics to compare 9X to other programs to gain insight and ensure reasonableness. + Influence and drive all cost pools in the… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA guidance ... for changes to an approved (A)NDA + Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses. + Assess… more
- HCA Healthcare (Manchester, NH)
- …coverage paid 100% by Company. **About Catholic Medical Center:** Catholic Medical Center ( CMC ) is an acute-care hospital owned by HCA Healthcare, and a regional ... health system based in Manchester, New Hampshire, with a commitment to delivering the highest quality and most advanced healthcare to patients across the state. Catholic Medical Center is part of the largest health system in New Hampshire, with 330 licensed… more