Company: CYNET SYSTEMS
Posted on: January 15, 2023
- 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
- Must be familiar with design change, design verification and
validation requirements for products and processes.
- Should be able to plan and execute assay verification and
- Position will be as an individual contributor no personnel
management experience is required, however it is expected that the
person will have excellent oral and written communication skills
and be able to effectively function as part of a broad
Essential Knowledge, Skills and Abilities, Preferred Education,
- Bachelor s degree required but advanced degreed candidates and
those with sufficient directly relevant experience strongly
- Technical focus should be in Biochemical Engineering,
Biochemistry or Chemical Engineering.
- Other disciplines may be considered for candidates with
extensive design transfer and/or process experiences.
- Applied knowledge and at least 3 years of direct experience
preferred in the development of manufacturing processes for
biochemical reagents and/or pharmaceuticals.
- Specific experience in the manufacture of products used in
clinical diagnostics is preferred.
- Project Management training and experience is a plus.
- Should be 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.
- Knowledge of statistical Process Control 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.
- Ability to build strong working relationships in
cross-functional project teams to develop technical solutions to
Keywords: CYNET SYSTEMS, Newark , Chemical Engineer, Engineering , Newark, Delaware
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