- Novo Nordisk Inc. (Durham, NC)
- …is responsible for supervising QC activities and personnel within the Stability and Support Teams. Additional responsibilities includes ensuring testing of ... in-process, release, and stability samples are performed in accordance with cGMP, NNPILP...Functions Lead team in successful execution of QC and Stability activities based on assigned area of accountability Coordinate… more
- Formation Bio (New York, NY)
- …method development, method verifications/qualifications/validations, degradation pathway studies, stability , and others). Technology transfer: Support the transfer ... developing, optimizing, and validating analytical methods for characterization and stability of large molecules. Experience with proposing and establishing drug… more
- Cepheid (Miami, FL)
- …knowledge to plan, design, development, test, analyze testing data and document stability studies to establish the product shelf-life.This position is part of the ... Product Life Cycle Quality & Stability team. It will be in Sunnyvale, California as...IVDR, and other applicable global standards.Fulfill all quality planning, stability , and risk management deliverables with feedback from cross-functional… more
- Merck & Co. (Rahway, NJ)
- …execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of ... Process, Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Stability Testing, Technical Writing-Preferred Skills:Job Posting End Date:07/2/2025 *A… more
- Novo Nordisk Inc. (Durham, NC)
- …what matters. The Position Perform & review analysis of in-process, release & stability samples in accordance with cGMP, site & corporate policies & procedures. ... Relationships Reports to Supervisor, QC - OFP. Essential Functions Accuracy & Scientific Soundness of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing proficiency for methods Timeliness of Lab Results & Investigations Operational… more
- Merck & Co. (Rahway, NJ)
- …to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, ... and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact… more
- Tris Pharma (Monmouth Junction, NJ)
- …analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples and executes physical characterization studies to facilitate product ... understanding. The incumbent also performs other lab assignments including, but not limited to: maintenance and calibration of analytical instruments, carries out and documents laboratory work to support product development and analytical method development… more
- Merck & Co. (Rahway, NJ)
- …and characterization such that the process is scalable without compromising stability , safety, efficacy, and delivery. -During development, we leverage smart ... experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly… more
- Merck & Co. (Sacramento, CA)
- …with In-Process Controls, drug substance and drug product release, stability , and extended characterization testing for vaccines and biologicsExperience with ... regulatory requirements and guidelines according to ICH, USP, Ph. Eur., and JP.Strong organizational and project management skills to handle multiple project associated tasks simultaneously.Strong oral and written communication skills to effectively… more
- Merck & Co. (Rahway, NJ)
- …for validating and performing CCIT for clinical supply release and stability testing according to specifications for all programs including vials, medical ... device components and combination products.Responsible for performing validation activities to support commercial method validation and transfer activities in collaboration with analytical projects leads and Device Development & Technology, Development… more
- Merck & Co. (Durham, NC)
- …systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.Assists the ... Automation Lead in the training, development, motivation, and assignments for employees and contractors.Coordinates projects with staff group for timely implementation.Uses technical knowledge to assure the efficient operation of variety of automated… more
- Merck & Co. (Durham, NC)
- …systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade. Assists ... in the Automation Lead in the training, development, motivation, and assignments for employees and contractors. Coordinates projects with staff group for timely implementation. Uses technical knowledge to assure the efficient operation of variety of automated… more
- Merck & Co. (Rahway, NJ)
- …to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, ... and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact… more
- Merck & Co. (Rahway, NJ)
- …molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling up the formulation, ... device, and manufacturing process.- Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively… more
- Merck & Co. (Rahway, NJ)
- …molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling up the formulation, ... device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively… more
- Aequor (Swiftwater, MN)
- …- Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations - Provide first level diagnostic of incidents and ... support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical - Responsible for the master data management process including the updating of specifications and supporting the approval process - Manage… more
- AUROBINDO (Durham, NC)
- …on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques ... (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Work with supervisor to plan and make adequate… more
- Aequor (Tampa, FL)
- …USP and regulatory requirements for raw materials, finished products, and stability samples. Perform environmental monitoring which includes water sampling and ... testing. Performs microbiology methods and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations. Manages change controls effectively. Manages/ supports microbiology projects from production or formulations… more
- Merck & Co. (South San Francisco, CA)
- …ProteinMPNN and AlphaFold, using AI-driven approaches to predict protein stability , function, and interaction.Oversee the integration of structural biology data ... into machine learning models to improve predictive capabilities.Foundation Models: Lead initiatives to develop foundation models that enable scalable and efficient molecular and protein design workflows.Conduct research on transfer learning and few-shot… more
- Merck & Co. (Rahway, NJ)
- …problematic residual host cell proteins that may impact product safety, efficacy, and stability . The qualified candidate is expected to be a leader in new technology ... platform and scientific innovation, and also expected to communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate in cross-functional teams.-… more
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