Manufacturing Biochemist

Company: Hired by Matrix
Location: Newark
Posted on: January 16, 2023

Job Description:

If you want more than just an assignment and to work with an organization that values your contribution to our growth AND has deployed a proprietary Consultant Appreciation Program (CAP) to continue to support your job search efforts in the future........Hired by Matrix could be just what you need. We are a distributed organization working with some of the premier Fortune 500 organizations across the US in multiple verticals and disciplines. If you embrace positive culture, a dynamic teaming approach, robust benefits, 401k matching, paid time off, and want more than just your next assignment........we are a great "Match."

Hired by Matrix has been providing talent solutions to help organizations enhance team capacity for decades. As a full-service search firm, we have partnered with companies across industries, including Financial Services, Fintech, Consumer Goods and Services, Security and Logistics, Pharmaceutical / Biotech, Technology, Automotive, Engineering, and Healthcare.

Job Description

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• Participate in the transfer of new clinical chemistry and immunoassay products from R&D into manufacturing.
  
• Develop the understanding of the critical quality aspects of the biologic products the design of which is to be transferred into manufacturing as well as the details of the manufacturing system used.
  
• Working closely with an internal team to understand the components of the products and assisting in the documentation to enable the procurement, receipt and testing of those components and the establishment of a bill of materials for the products in an SAP-based ERP system.
  
• Working closely with various functions (operations, procurement, manufacturing planning, quality assurance, process engineering, etc.,) in the manufacturing plant to help establish the process/workflow for the manufacture of the product, help author the validation plans for the processes established and to help author the operating instructions, worksheets and other documentation as necessary to produce the product.
  
• Evaluation of process equipment to produce custom formulated liquid reagents as well as automated material handling equipment to label and package final product.
  
• Physical/chemical characterization of product, metrology, performance testing and working with team to correlate impact of process parameters on end-use product.
  
• Documentation of processes, validations and authoring technical protocols, reports and testing procedures in a regulatory-compliant environment.
  
• Development of/or management of external partners that may produce critical raw materials.
  
• Interpreting analysis of instrument-chemistry interactions for clinical chemistry methods to understand sensitivities of product to manufacturing processes.
  
• Lead and conduct troubleshooting activities as necessary to determine the root cause for failures and identify and verify corrective actions.
  
• Familiar with design change, design verification and validation requirements for products and processes.
  
• Plan and execute assay verification and validation studies.
  
  Qualifications
  
  
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  • Bachelor's degree required but advanced degree and with sufficient directly relevant experience strongly preferred.
    
  • Technical focus should be in Biochemical Engineering, Biochemistry or Chemical Engineering.
    
  • 3 years of direct experience preferred in the development of manufacturing processes for biochemical reagents and/or pharmaceuticals.
    
  • Knowledge &/or experience with chemical/biochemical processes and ideally clinical diagnostic products and in operating in a FDA-regulated environment.
    
  • It is preferred, but not required, that the prior experience with standards and calibrator products used in the clinical diagnostics industry, and have experience or familiarity with managing the support of commercial products.
    
  • Specific experience in the manufacture of products used in clinical diagnostics is preferred.
    
  • Project Management training and experience is a plus.
    
  • Knowledgeable about FDA and other external regulatory agency requirement including cGMP, familiar with safety aspects of biohazardous materials; provide technical support for regulatory submissions/registrations.
    
  • Additional relevant technical experiences may include: biochemical/chemical manufacturing experience, fluid process design (precision dispensing/filling equipment, mixing, filtering, etc.,) fluid test/analysis methodologies (conductivity, flow, IR, HPLC, etc.,), electrochemistry/electrochemical sensor manufacture, tableting, physical pharmacy,
    
  • Experience in experimental design, use of DOE and statistical analysis software is a plus.
    
  • Statistical Process Control knowledge is necessary.
    
  • Relevant work experiences may include: In-vitro diagnostic or pharmaceutical product manufacture. manufacturing, compounding and processing of pharmaceuticals,
    
  • Apply scientific and statistical principles and provide technical leadership to perform a wide variety of technical investigations arising out of reagent performance issues encountered during reagent manufacturing.
    
  • Working knowledge of clinical chemistry and application of automated assays in clinical chemistry laboratories.
    
  • Build strong working relationships in cross-functional project teams to develop technical solutions to problems.
    
    Please submit your resume for consideration. Once submitted, feel free to contact Vasu at 201-497-1998 -for additional information.
    
    Approx. Duration: 12 Months
    
    About Hired by Matrix
    
    Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full-service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
    
    Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option with a company match after one year.
    Equal Opportunity Employer
    WBENC Certified
    WOSB Certified
    
    We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!
    
    Connect with us on LinkedIn and see how we can impact your career!
    
    Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/

Keywords: Hired by Matrix, Newark , Manufacturing Biochemist, Other , Newark, Delaware