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Perform in vitro dissolution testing using USP dissolution apparatus 1, 2 and 3, perform dissolution method development, validation, and assessment of results with minimum guidance. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
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Execute research and development in accordance with the FDA mandated design control requirements on projects that include process and product development, validation and verifications, and improvement opportunities for new and existing products.
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Designs and implements method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others OR designs and performs multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (GC, ICP-MS, LC/MS, GC/MS etc.
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Center 1 (19052), United States of America, McLean, VirginiaSenior Associate Data Scientist, Audit Data Science. Senior Associate Data Scientist, Audit Data Science page is loaded.
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Extensive expertise in U/HPLC, IC, colorimetric assays, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
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Knowledge and experience in high performance liquid chromatography (HPLC) method development and validation for drug formulation analysis. Participate in the development, qualification, and validation of new analytical methods.
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Assisting with development, validation, and running of novel biomarker assays. Running of biomarker assays on the above samples (including pPCR, standard and ultra-sensitive ELISAs, and potentially flow cytometry.
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Sirius Staffing is seeking a Lab Technician/Associate Scientist for a temp to perm opportunity in Birmingham, AL. Please contact us today for more information. Documentation-Assists in executing validation protocols to comply with currentindustry practices and regulatory requirements.
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The Formulation Scientist , reporting to the Associate Director, Product Development, will provide support for the formulation and process development activities at CDMO/CMO using concepts of Quality by Design (small molecules in injectable and oral dosage forms preferred) for ANDAs and NDAs. Experience with peptides chemistry and characterization techniques is a plus.
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We have an URGENT need for a remote Formulation Scientist for a growing Pharmaceutical Company. Reviews documentation including pre- and post- execution manufacturing and packaging batch records, tech-transfer protocols/reports, process validation protocols/reports, stability protocols/reports, method validation protocols/reports, investigations and deviations and related corrective and preventive actions.
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Applying a working knowledge of formulation sciences, the scientist will support pharmaceutical product development from development phase till commercialization of the product that includes but is not limited to pre-formulation, formulation, and process development by partnering with CDMOs.
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Experience in the unique requirements associated with the development and manufacture of sterile peptide products is desirable. Injectable with peptide experience is preferred. Hands on experience working in formulation lab and reviewing production batch records.
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Knowledge of regulatory systems and guidelines such as USP/EP/BP, ICH, FDA. A valid U.S. passport or required documents for international travel is required. Powder and liquid formulation experience is preferred.
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Review relevant CMC sections for ANDA/NDA submissions in timely manner. Prepare or review protocols and reports for testing associated with pre-formulation studies, overall formulation design, filter validations, manufacturing equipment/components compatibility, container closure selection, E&L studies and similar.
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Strong communication and technical writing skills. Under the guidance of team lead or department leader, manage multiple projects simultaneously to meet deadlines. MS in pharmaceutical sciences or advanced science/healthcare degree with 3-4+ years of experience.
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