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Process Development Associate I Resume Example

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PROCESS DEVELOPMENT ASSOCIATE I
Professional Summary

Highly focused and detail-oriented individual eager to apply advanced studies and research experience to the fields of Sciences. An innovative scientist with deep passion for solving problems. Strong record of working in high-functioning teams to find solutions. Expertly skilled at process development, cellular assays and GMP.

Work History
Alexion Pharmaceuticals - Process Development Associate INew Haven, CT07/2019 - Current
  • Contribute to analytical method evaluation, validation, assay development and transfer in the laboratory.
  • Develop implement and test new methods and technologies to optimize analytical methods for the current pipeline and assist to manage cross-functional technology transfer projects.
  • Hands-on experience with Cell-based potency assay (Hemolytic).
  • Hands-on experience with ELISA (HCP).
  • Experience with CMO and CRO for method optimization and transfer.
  • Detailed knowledge and compliance with GxP procedures and policies.
  • Compliance with FDA regulatory requirements.
  • Assist with the development of SOPs and the ongoing maintenance of process and procedure documentation.
  • Help draft analytical transfer protocols and reports for late-stage clinical and commercial programs such as Size exclusion chromatography, Imaged capillary electrophoresis, Tryptic peptide mapping, Cell-based potency assay.
  • Ability to perform laboratory tasks such as preparing buffers, samples, calibrating equipment.
  • Experience with instrumental and statistical software such as SoftMax Pro, EXCEL, JMP.
  • Maintain detailed and accurate laboratory notebook, good documentation practices, and record keeping.
  • Excellent verbal and written communication skills, excellent technical writing skills, ability to work in teams as well as individually, meet deadlines, achieve goals, and strong work ethic.
  • Organized, self-motivated, data-driven, innovative, with the ability to work in a multicultural, multidisciplinary team setting.
University of Bridgeport - Graduate Teaching Assistant/University Lab InstructorBridgeport, CT08/2017 - 05/2019
  • Instructed an upper-division level Microbiology lab with 18 students.
  • Delivered lecture as well as a syllabus, study guides, conducted midterm and final examinations.
  • Experienced in BSL 1 and BSL 2 microorganisms, maintained and sub-cultured bacteria and fungi, prepared laboratory specimens, media, biochemical tests, dilutions and equipment, aseptic technique, pure culture, microbial limit testing, use of the microscope.
  • Performed microbial identification methods to identify strains of bacteria (ex.Grams staining, selective media, biochemical tests).
  • Adhered to SOP, GMP, MSDS requirements.
  • Record, stock, and inventory of chemicals, helped maintain cleanliness and laboratory organization, performed calibration, maintaining lab equipment, and safe environment in the lab.
  • Excellent verbal written communication skills, ability to multitask, and attention to detail.
RemediumOne (Pvt) Ltd, Colombo, Sri Lanka - Clinical Research CoordinatorColombo, Sri Lanka11/2016 - 06/2017
  • Coordinated trial activities in Phase III, double-blind, placebo-controlled trial to investigate the efficacy, safety, and immunogenicity of a tetravalent Dengue vaccine study.
  • Supported principal investigators and clinical team at the site by attending to protocol-defined visits on time.
  • Adhered to standards in all areas, including SOP, GLP, GCP, LIMS, EDC, research protocols, and regulatory reporting.
  • Managed serious adverse events, protocol deviations, screened and recruited subjects, obtained informed consent, source documentation, facilitated monitoring, and clinical sample handling.
  • Implemented approved recommendations for audit finding, workflow management, and querying, scheduled study visits maintained accurate records ensured compliance with study protocols.
  • Effectively communicated with families, medical staff, providers to effectively coordinate study procedures set forth by the sponsor.
  • Collaborated with investigators to prepare presentations, reports, clinical study, results, procedures, results, and conclusions.
GlaxoSmithKline Pharmaceuticals - Quality Control Analyst (Intern)Colombo, Sri Lanka04/2014 - 06/2014
  • Worked at the QC laboratory where raw material and product specification methods were followed to achieve compatible drugs.
  • Executed activities associated with optimization, transfer, validation, and life cycle management of test methods used for release testing of raw materials and finished products.
  • Conducted experiments on incoming raw materials and finished products by conducting specification methods by visual and chemical measurement methods.
  • Experienced in titrimetric assays, absorbance spectrophotometer, measurement of specific gravity, loss on drying, ion-exchange chromatography, product identification methods.
  • Ensured complete compliance with QMS, SOP, GMP, MSDS required by the company and regulatory agencies.
  • Ensured compliance with good laboratory practice and safety regulations within the laboratory.
https://www.linkedin.com/in/sarala-francis

LinkedIn

  • LinkedIn : https://www.linkedin.com/in/sarala-francis
Education
05/2019University of BridgeportBridgeport, CTMaster of Science: Molecular Biology & Biomedical Sciences
  • GPA: 4.0
  • Master's Thesis: Investigation of the inhibitory effects of Metformin on Leishmania major promastigotes. Cultured Leishmania promastigote cells, prepared necessary media, performed serial dilutions, and used hemocytometer and microscope to count cells to determine the IC50 value of the drug, analyzed data, and interpreted it for further analysis.
04/2016Christ UniversityBangalore, IndiaBachelor of Science: Biotechnology, Chemistry, Zoology
Skills
  • ELISA
  • PCR
  • LIMS
  • Cell-based potency assay
  • GMP
  • Cell Culture
  • Quality Control
  • Aseptic technique
  • Molecular Biology
  • Microsoft Excel
  • Microsoft Word
  • Microsoft Powerpoint
  • Ion exchange chromatography
  • Troubleshooting
  • Data Analysis
  • Assay development
  • JMP statistical software
  • Leadership
  • Decision Making
  • Excellent organizational skills
  • Excellent communication skills
  • Teamwork
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Resume Overview

Companies Worked For:

  • Alexion Pharmaceuticals
  • University of Bridgeport
  • RemediumOne (Pvt) Ltd, Colombo, Sri Lanka
  • GlaxoSmithKline Pharmaceuticals

School Attended

  • University of Bridgeport
  • Christ University

Job Titles Held:

  • Process Development Associate I
  • Graduate Teaching Assistant/University Lab Instructor
  • Clinical Research Coordinator
  • Quality Control Analyst (Intern)

Degrees

  • Master of Science : Molecular Biology & Biomedical Sciences
    Bachelor of Science : Biotechnology, Chemistry, Zoology

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Process Development Associate I

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