Company: Hired by Matrix
Posted on: January 16, 2023
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
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.
- 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
- 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
- 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
- Familiar with design change, design verification and validation
requirements for products and processes.
- Plan and execute assay verification and validation studies.
- Bachelor's degree required but advanced degree and with
sufficient directly relevant experience strongly
- 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
- 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
- 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
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
We work hard to match our candidates with the right career
opportunities. Let us find you a #MatrixMatch so you can reach your
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Keywords: Hired by Matrix, Newark , Manufacturing Biochemist, Other , Newark, Delaware
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