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Analytical Development, Vaccine Development, GMP, quality control, compliance, investigation and analysis, method validation, method transfer, regulatory filing, Large Molecule, analytical method, regulatory standard, glp, validation protocol, analytical methods, release, stability, in-process assays, technical liaison, deviations, investigations, drug development, ICH, CMC guidance documents.
ExpandApply NowActive JobUpdated 22 days 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.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Ensure tasks are conducted in accordance with study protocols, data transfer agreements (DTA), SOPs, and other regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Serve as a member of the global Immunology, Cellular and Molecular Analytics leadership team, contributing to strategic planning and collaboration across the CMC network (including Belgium, Italy and US sites), and maintaining strong collaboration and interaction both locally and globally with internal (within TRD) and external partners (Discovery, Preclinical, GSC (Global Supply Chain), Quality, Regulatory, Universities, etc.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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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 1 month ago - UpvoteDownvoteShare Job
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Oversee the preparation, review, and approval of the Validation Master Plan (VMP) for headquarters and point-of-care facilities, ensuring alignment with regulatory expectations. This role will work closely with cross-functional teams including Manufacturing, Pharmacy, Validation, Regulatory, and Quality Control Operations as well as supervise contractors to help ODP achieve its organizational objectives and ensure the consistent production of high-quality pharmaceutical products.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Responsible for chemical process development and optimization, technology transfer, scale-up, and process validation of APIs. The Associate Director chemical development will assist with the preparation and review of drug substance sections for regulatory submissions and will be responsible for the preparation and technical review of GMP documents for API, intermediate, and RSM manufacture.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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This team member will report to Quality Head and be responsible for supporting our cGMP manufacturing processes comprised of Commissioning, Qualification and Validation (CQV), Computer System Configuration Management, Computer System Validation (CSV) and quality regulatory compliance, assistance with the commissioning and qualification of AbelZeta’s robust manufacturing, supporting validation and implementation of new equipment as well as maintaining the Validation Master Plan.
$181,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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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This position will support Quality Control through involvement with complex analytical and/or manufacturing investigations, method troubleshooting, method validation/transfer, and authoring of CMC analytical sections in support of regulatory filings/responses.
ExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality as well as alliance partner counterparts, as applicable. Delivers analytical source documentation for CMC sections of IND/BLA filings and addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
Full-timeExpandApply NowActive JobUpdated 22 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 1 month ago - 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 9 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 2 months ago - UpvoteDownvoteShare Job
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The successful candidate will play a critical role in designing and implementing the clinical product development, CLIA validation plans, ensuring compliance with regulatory requirements, and effectively communicating with clients, the sales team, and the laboratory director.
Full-timeExpandApply NowActive JobUpdated 7 days ago
validation regulatory jobs in Gaithersburg, MD
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