- Merck & Co. (Rahway, NJ)
- …authoring regulatory filings for sterile dosage forms especially biologics ( liquid / lyophilized/ complex systems).The candidate should have experience with ... technology transfer to facilitate scale-up of early phase and late phase biologic drug product manufacturing processes to GMP production facilitiesThe candidate should have strong familiarity with relevant biologic analytical methods and specifications for… more
- Novo Nordisk Inc. (Boulder, CO)
- …of a kilo lab pilot facility Direct development and scale-up of liquid phase batch processes used to generate small molecules, oligonucleotide Intermediates, and ... API's Analyze research data to identify and evaluate problems and determine appropriate solutions utilizing an array of analytical techniques Support regulatory filings as necessary Support the overall Chemical Development team goals with accurate budget and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology Therapeutic area with Medical / Scientific acumen in Solid and Liquid tumors, understanding of the CDISC (SDTM, ODM.XML, CDASH) industry standards, Metadata ... management and Data Mappings and are some of the key requirements of this role. This role also requires leadership for the continued development and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …automation technology and vendor offerings specific to commercial analytical platforms, liquid handling & sample handling systems Extensive knowledge in analytical ... best practices, industry standards and the latest technologies Ability to think critically and demonstrated troubleshooting and problem-solving skills. Results driven with strong analytical, problem solving and critical thinking skills. Strong experience… more
- Aequor (Thousand Oaks, CA)
- …Execute timely critical reagent analytical support and characterization using liquid chromatographic and analytical methods such as RPLC-MS, native-MS, aSEC, ... aCEX, aHIC, calorimetry, and light scattering. Generate and process singleton and large analytical data sets for research clients. Generate reports and communicate these data and associated reports for research clients. Perform protein, peptide, nucleic acid,… more
- Insmed Incorporated (Bridgewater, NJ)
- …characterization of multiple dosage forms including solid oral, liquid dosage, inhalation and combination products.Experience with analytical instrumentation ... such as HPLC/UPLC, SEC, CAD, SEM, Dissolution, GC, and KF are a must. Experience with SEC-MALS and MS are a plus.Strong statistical skills with a good understanding of basic and intermediate statistical tests.Good understanding of GxP, CMC, ICH and compendial… more
- Aequor (Bothell, WA)
- …2) may be required. May work in areas with exposure to vapor phase liquid nitrogen. Must be able to work nights, weekends, mandatory bi-weekly overtime, and holidays ... in a 12-hour shift structure. Shift: 4pm to 4:30 am Wed, Thu, Fri alternate Sat Additional Job Requirements: None more
- BioAgilytix (Durham, NC)
- …communication skills.Trouble shooting equipment (Plate washers, Plate readers, Liquid handling equipment, Etc.) Supervisory ResponsibilityThis position has no ... supervisory responsibilitySupervision ReceivedFrequent supervision and instructionsInfrequently exercises discretionary authorityWorking EnvironmentPrimarily office and receiving dockRoutinely uses standard office equipment such as computers, phones,… more
- Aequor (Devers, TX)
- …with handling patient blood and blood derived drug products as well as liquid nitrogen handling.The incumbent is responsible that all finished goods are packed in ... accordance to specifications and for completing all packaging documentation required before line start-up and during the packaging process. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and cGMP's.… more
- Tris Pharma (Monmouth Junction, NJ)
- …skills (4 yrs exp). Required skills include: working with solid and liquid dosage forms in pharmaceutical setting; following cGMPs and FDA guidelines; writing ... protocols and reports, including SOPs, investigations, root-cause analyses; Microsoft Office; JDE (inventory management) and MC (documentation/QMS/eBR); and vendor management. more
