at Acara Solutions in Newark, Delaware, United States
Acara Solutions is looking for a Manufacturing Biochemist for our client located in Newark, DE
This role is for a person to engage as part of a team with client's staff to participate in the transfer of new clinical chemistry and immunoassay products from R&D into manufacturing.
This role will need 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 an SAP-based ERP system.
It will also entail working closely with various functions (operations, procurement, manufacturing planning, quality assurance, process engineering) 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 or management of external partners that 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.
Provide technical support for regulatory submissions/registrations.
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.
Pay and Benefits:
The Salary for this position is $50.00 per hour (Max Pay rate).
Required Skills / Qualifications:
Minimum of a bachelor's degree in Biochemical Engineering or Biochemistry or Chemical Engineering.
Minimum of 3 years' experience with chemical/biochemical processes and ideally clinical diagnostic products and in operating in an FDA-regulated environment.
Minimum of 3 years' experience with biochemical/chemical manufacturing, fluid process design (precision dispensing/filling equipment, mixing, filtering) fluid test/analysis methodologies (conductivity, flow, IR, HPLC), electrochemistry/electrochemical sensor manufacture, tableting, physical pharmacy.
Minimum of 3 years' experience in In-vitro diagnostic or pharmaceutical product manufacture. manufacturing, compounding, and processing of pharmaceuticals.
Preferred Skills / Qualifications:
Master's degree in Biochemical Engineering or Biochemistry or Chemical Engineering.
Minimum of 3 years' experience in the development of manufacturing processes for biochemical reagents or pharmaceuticals.
Specific experience in the manufacture of products used in clinical diagnostics.
Project Management training and experience.
Experience in experimental design, use of DOE and statistical analysis software.
Experience with standards and calibrator products used in the clinical diagnostics industry.
Personnel management experience.
Knowledge of statistical Process Control is necessary.
Working knowledge of clinical chemistry and application of automated assays in clinical chemistry laboratories.
Ability to build good working relationships in cross-functional project teams to develop technical solutions to problems.
Knowledgeable about FDA and other external regulatory agency requirement including cGMP, familiar with safety aspects of biohazardous materials.
Familiarity with managing the support of commercial products.
Familiar with design change, design verification and validation requirements for products and processes.
Able to plan and execute assay verification and validation... For full info follow application link.
Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.