Biological/Chemical Scientist/Engineer 1Contract
Delaware, Newark - 19702Job Simplification
The announced job offer is made public by the firm: CorTech LLC and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.
It is announced that they have a job offer at the category of Trades & Services and the jobs location is in the state of Delaware at the city Newark, in the country US - at this current ZipCode: 19702
The information residing in this page is not directly announced by our websites, we help users in the intent of finding the jobs they want and redirect them back to jobs8 for apropriate applying to any of the jobs listed on www.greenenergyjobsonline.com.
Job Overview
For this role at our client, assignment is contingent upon the Employer of Record's receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, testing for COVID-19 may be available and/or required. Requests for accommodation will be considered pursuant to applicable law.
shift timings :8:00 AM - 4:30 PM
Job Description:
This role is for a person to engage as part of a team with client Healthineers staff to participate in the transfer of new clinical chemistry and immunoassay products from R&D into manufacturing.
This role will require the ability to 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. This will entail 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 a SAP-based ERP system. It will also entail 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.
The successful candidate should have 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 candidate have 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.
Key aspects will likely include exposure or ability to directly support the following objectives:
• 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. 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 validation studies
• 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 cross-functional team.
Essential Knowledge, Skills and Abilities, Preferred Education, Experience:
• Bachelor's degree required but advanced degreed candidates and those with sufficient directly relevant experience strongly preferred. 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 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. 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 problems
shift timings :8:00 AM - 4:30 PM
Job Description:
This role is for a person to engage as part of a team with client Healthineers staff to participate in the transfer of new clinical chemistry and immunoassay products from R&D into manufacturing.
This role will require the ability to 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. This will entail 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 a SAP-based ERP system. It will also entail 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.
The successful candidate should have 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 candidate have 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.
Key aspects will likely include exposure or ability to directly support the following objectives:
• 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. 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 validation studies
• 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 cross-functional team.
Essential Knowledge, Skills and Abilities, Preferred Education, Experience:
• Bachelor's degree required but advanced degreed candidates and those with sufficient directly relevant experience strongly preferred. 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 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. 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 problems
Employer Overview
CorTech LLC
Delaware, Newark - 19702- Agency