Elizabeth Cabrera

Experience

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  SUNY Stony Brook

  Aug 2002 - Jan 2009

  Graduate Student Researcher, Department of Molecular and Cellular Pharmacology

  2006-2009• Discovered novel binding sites between myosin phosphatase and protein phosphastase 1 using protein structure prediction models, site-directed mutagenesis, and protein overexpression in mammalian cells2002-2006• Examined the role of ubiquitination in the regulation of Ras activity via fluorescence microscopy, western blot analysis and co-immunoprecipitation assays

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  Brookhaven National Laboratory, Department of Biology

  Feb 2009 - Jan 2011

  Postdoctoral Research Associate

  • Overexpressed several endogenous cytoplasmic proteins identified as substrates for GroEL-mediated folding to examine effects on protein folding under conditions of saturated chaperone activity using an inducible E. coli culture system and SDS-Page gel electrophoresis

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  Stony Brook University

  Jan 2011 - Oct 2011

  Postdoctoral Associate, Department of Oral Biology & Pathology

  • Used various molecular cloning techniques to decipher the role protein kinase D (PKD) in wound healing and skin regeneration• Trained in mouse handling, genotyping, DNA and RNA isolation, PCR and RT-PCR

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  Altaire Pharmaceuticals

  Oct 2011 - May 2015

  Microbiologist and Technical Writer

  TECHNICAL ANALYST & WRITER • Responsible for the organization, writing and reviewing of procedures, protocols and studies for the formulation, manufacturing and validation of pharmaceutical drug products.• Experience in the preparation of material for Abbreviated New Drug Application (ANDA) submission for generic drug products to the Food & Drug Administration (FDA). MICROBIOLOGIST• Prepared and reviewed SOPS, investigation and summary reports for OOS/process deviations.• Responsible for method and procedure training for new laboratory members to confirm that process and safety protocols are met.• Conducted internal audits¬¬ for the Quality Assurance Department to ensure compliance to regulatory procedures.• Performed microbiological testing of products and raw materials, the reading of environmental monitoring plates from controlled areads, microbial identification work and other applicable duties in accordance with SOPs and Methods.• Routine functions required in a microbiology laboratory including microbiological identifications, growth promotion testing of media, media fill inspections, bioassay testing, inpection and calibration of laboratory instruments, and validation testing of products. Show less

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  Amneal Pharmaceuticals

  May 2015 - Jun 2019

  Technical Writer III

  • Successful filing of Abbreviated New Drug Application (ANDA) submissions for generic drug products to the Food & Drug Administration (FDA) in an timely fashion to meet internal timelines.• Ability to develop and improve current templates for CMC filing to reflect current QbD formats from the Food & Drug Administration.• Capable of writing and reviewing a variety of technical documents including study protocols, batch records and regulatory filing documents.• Prepare manufacturing batch records detailing the formulation and manufacturing process of various dosage forms.• Draft and review the product development report in conjunction with primary formulation scientist to produce a document that is legible and easy to understand so that it is acceptable for filing.• Coordinates and tracks data required from other departments for the product development report. Show less

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  Lachman Consultant Services

  Jun 2019 - now

  • Support the President & CEO. Effectively interact with / follow the guidance of Executive Management. • Work collaboratively with members of Compliance, Science & Technology, Regulatory, and other Practices to ensure communications are clear, concise, and easily understood.• Write, revise, and review documents/communications to ensure high-quality end-product that contributes to the overall success of client communications. This may include, among other items, audit reports and FDA / regulatory agency communications.• Prepare, write, update, and maintain SOPs, including the preparation of any forms or attachments that may accompany the SOP.• Generate and maintain standardized templates. Responsible for document templates to ensure they are maintained, consistent across processes / practices, conform to cGMP standards, are user friendly, clear, and remove redundancies.• Interact with writers and reviewers to evaluate and finalize reports, GMP/GLP documents, protocols, IQ/OQ/PQ documents, investigations, CAPAs, change controls, product development reports, scale-up documents, as well as technical operations, validation and equipment qualification activities, audits, batch records, SOPs, and other related items.• Work independently and within a team on special nonrecurring and ongoing projects. • Design, develop, and type general correspondence, SOPs, technical documents, etc. Proofread copy for spelling, grammar and layout, making appropriate changes. Responsible for accuracy and clarity of final copy. Show less

  • Manager, Project Support

    Feb 2022 - now

  • Senior Technical Writer / Documentation Specialist

    Jun 2019 - Feb 2022