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Write, edit, and review analytical sections of CMC regulatory filings. A good understanding of FDA and ICH guidelines and practical knowledge with assay validation and cGMP will be advantageous.
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Manages, develops and/or oversees the Quality team's responses to all QMS issues to timely close including; non-conformances, performance of Risk Assessments, CAPA investigation and support, design validation, QMS improvements and enhancements, NCR's, compliance with regulations, policies, procedures, external and internal audits, Technical support issues, etc.
$200,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Contribute to the development of master plans and validation strategies for a variety of manufacturing processes, adhering to regulatory requirements and compliance. Your Role We are hiring an experienced Validation Engineer to support multiple commissioning, qualification, and validation projects.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Demonstrated experience in bioanalytical assay development and validation. Associate Director level will collaborate closely with senior bioanalytical leaders in the organization and provide support in drafting such regulatory responses.
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Prepare/review development reports, tech transfer and process validation documents, regulatory submissions. Familiarity with risk assessments and Regulatory submissions (especially BLA.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Writes high-quality validation documentation that satisfies the client’s internal model approval functions, audit requirements, and regulatory standards. The Senior Manager, Valuation & Capital Market Analytics – Model Risk Management (MRM) is responsible for managing the execution and delivery of challenging Model Risk Management related engagements by performing risk management related activities such as designing effective challenge and validation of models, independent review of model documentation and governance, writing high quality model validation reports and will the initial proposal preparation through project completion.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Knowledge of compendia, regulatory requirements for QC testing, and qualification/validation pertaining to the pharmaceutical industry, specifically cell therapy. Support the day-to-day operation of the QC analytical lab to assure products met testing requirements, and laboratory operation and systems comply with regulatory requiremnts.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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He/she will work closely with research, manufacturing, validation, quality and regulatory functions to support development of molecules leading to commercialization. Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Biologics Process Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Supporting preparation of UFP-QAPPs, data validation narratives, and data usability reports. Familiarity with USEPA analytical methods for the preparation and analysis of samples from various media and under different environmental regulatory programs (e.g., RCRA, CERCLA, DoD, DOE, USEPA, state waste disposal requirements.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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This role is pivotal in the development, qualification, and validation of molecular separation assays for testing vaccine products. Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Assist during external audits associated with MSD's active regulatory certifications as well as customer audits. Serve as Quality representative on validation activities (e.g. equipment, process, assay, spreadsheet, software, facilities and utilities.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ensure protocols adhere to in 21CFR Part 211 and EU Annex 1 and are aligned with quality policies, procedures, and the Validation Master Plan (VMP) of the Gaithersburg site. Demonstrated understanding of regulatory requirements relevant to equipment qualification in the biotech or pharmaceutical industry, including cGMP, GLP, and GAMP guidelines.
ExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Proven record of delivering projects on time and within budget while adhering to regulatory requirements. Minimum of a bachelor’s degree in a scientific field such as Biology, Chemistry, Biochemistry, Engineering, or related discipline.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Be responsible for bioanalytical and immunoassay method development (PK, ADA, Nab, ELISA, MSD and Luminex), validation and sample management/analysis in support of preclinical and clinical drug development, and biotherapeutics services tasks by maintaining the integrity of data in compliances with standard operating procedures (SOPs) and GxP (e.g., GLP, GCP, GMP, GCLP) regulatory guidelines.
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validation regulatory jobs in Potomac, MD
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