- Curia (Albuquerque, NM)
- Manager , Analytical Chemistry in Albuquerque, NM Build your future at Curia, where our work has the power to save lives. Curia is a global contract ... contributions + Learning platform + And more! Summary: The Manager of Analytical Chemistry is...chemistry leadership role + Five (5) years of chemistry experience within an aseptic/sterile environment and GMP… more
- BeOne Medicines (Pennington, NJ)
- …test results in support of manufacturing operations. + Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures. ... a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and...+ Lead troubleshooting efforts for analytical methods and instrumentation related to CE. + Conduct… more
- Cambrex High Point (High Point, NC)
- …Higher level of understanding of the principles of cross-functional departments, including analytical chemistry and engineering. + GMP /Regulatory Knowledge: ... of projects for internal and customer use. + Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource… more
- Cambrex High Point (Durham, NC)
- …level of understanding of the principles of cross-functional departments, including analytical chemistry and engineering. GMP /Regulatory Knowledge: ... + and customer use. + Work closely with other chemistry and analytical laboratory staff to coordinate...meetings with customers. + Work closely with manufacturing and GMP operations to coordinate project related equipment + and… more
- United Therapeutics (Morrisville, NC)
- …outside of the box, troubleshoot, and make fast but accurate decisions. The QA Manager , Analytical Services will ensure the timely and accurate Quality oversight ... for QC chemistry and microbiological testing of materials and UTC combination...scientific field + 8+ years of experience in a GMP pharmaceutical QC laboratory with a Bachelor's Degree or… more
- Danaher Corporation (Logan, UT)
- …you will do: + Lead and manage a global team of scientists across analytical chemistry , cell culture, and stability services, setting priorities and evaluating ... /GLP regulated laboratory environment + Understanding of ICH and FDA guidelines + Analytical chemistry techniques including ICP/MS, GC/MS, LC/MS and UPLC Cytiva,… more
- Cambrex High Point (Charles City, IA)
- … Development, Chemical Development, Process Support Group and Quality Control. + Perform analytical chemistry assays based on new and existing methodologies + ... GMP SOPs and DEA regulations + Transfer documented analytical methods to the QC and Process Support Group...+ May also perform other duties as required. Qualifications/Skills Analytical Chemistry Knowledge : Beginning to demonstrate… more
- Cambrex High Point (Minneapolis, MN)
- … Development, Chemical Development, Process Support Group and Quality Control. . Perform analytical chemistry assays based on new and existing methodologies . ... GMP SOPs and DEA regulations . Transfer documented analytical methods to the QC and Process Support Group.... May also perform other duties as required. Qualifications/Skills Analytical Chemistry Knowledge: Good understanding of the… more
- Cambrex High Point (Minneapolis, MN)
- … Development, Chemical Development, Process Support Group and Quality Control. . Perform analytical chemistry assays based on new and existing methodologies . ... GMP SOPs and DEA regulations . Transfer documented analytical methods to the QC and Process Support Group.... May also perform other duties as required. Qualifications/Skills Analytical Chemistry Knowledge: Strong understanding of the… more
- J&J Family of Companies (Spring House, PA)
- …Development - Biologics to be located in Spring House, PA.** **Purpose:** The Scientific Manager Analytical Development - Biologics will be part of an exciting ... team establishing an at-line automated analytical testing lab and leading the...Lead all aspects of the daily operations of the GMP automation lab, ensuring efficient utilization of resources. Managing… more
- Hovione (East Windsor, NJ)
- …Sciences fields (desired) - Typically requires 3-5 years of relevant experience in Analytical Chemistry and /or Scientific background in relevant field (PhD ... and Project manager to ensure that the timelines of the analytical work (such as method development, validation protocols, validation execution, and validation… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three ... The Senior Manager , Global Product Quality - Biologics is responsible...that is in accordance with regulatory expectations and applicable GMP /GDP quality standards. This role will provide specialized Biologics… more
- BeOne Medicines (Pennington, NJ)
- …Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished ... Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + Oversee QC...and, scheduling, etc. + Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell… more
- Kelly Services (Princeton, NJ)
- …supporting major regulatory submissions (eg, BLA, NDA, MAA). + Proficiency with analytical chemistry methods including HPLC, UPLC, GC, TOC, and related ... **QC Project Manager - BLA Filing- Princeton NJ** **General Description** The...Strong working knowledge of **USP/EP** , **cGMP** , **EU GMP ** , and analytical compliance requirements. +… more
- Curia (Hopkinton, MA)
- …team members on applicable techniques and equipment Qualifications + Bachelor's degree in Chemistry , Analytical Chemistry or related field + Minimum 5-8 ... of the Quality Control function at the site. The Manager will coordinate a wide variety of analytical...pass Occupational Health Screening Preferred + Advanced degree in Chemistry , Analytical Chemistry or related… more
- Astellas Pharma (Westborough, MA)
- …Japan guidance), Astellas policies and procedures and industry best practices. The Validation Manager will ensure that all critical GMP equipment and systems are ... **Validation Manager ** Do you want to be part of...programs, policies and procedures related to facilities, utilities, equipment, analytical equipment, cleaning validation and process performance qualification for… more
- Merck (Durham, NC)
- …lyophilization, product inspection, and quality control laboratories. The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support ... performance objectives and metrics. Consults on an as-needed basis with next level manager on more complex decisions. + Actively sponsor and develop a culture that… more
- Katecho (Des Moines, IA)
- … and FDA regulations pharmaceutical regulations.Skills: Strong leadership, analytical , and problem-solving skills. Excellent communication, organizational, and ... Surmasis Pharmaceutical - Quality Manager (M - F) + + Job Tracking...internal and external standards, including FDA, EMA, ICH, and GMP . + Regulatory Compliance: Ensure compliance with applicable pharmaceutical… more
- BeOne Medicines (Pennington, NJ)
- …Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished ... the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the...preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Ensure that the QC… more
- Kelly Services (St. Louis, MO)
- **Quality Manager ** **- (Greater St. Louis, MO Area)** **Sign-On Bonus** **Day Shift** The Quality Manager is a critical member of the **Site Leadership Team** ... operational challenges and identify work process improvements. + **Lead all GMP -related activities** on site, ensuring robust training and adherence to standards.… more
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