Here are the job position details for your review:

Job Title: Manufacturing Biochemist
Pay Rate: $42.50 to 50/Hr
Duration: 12 Months
Location: Newark, DE

This position is for the Healthcare Diagnostics division.

Job Description:

• This role is for a person to engage as part of a team with Clients-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 an understanding of the critical quality aspects of the biological 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, 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 the knowledge &/or experience with chemical/biochemical processes and ideally clinical diagnostic products and operating in an 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.

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Key aspects will likely include exposure or the 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 the final product
• Physical/chemical characterization of product, metrology, performance testing, and working with the team to correlate the impact of process parameters on the 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 the design change, design verification, and validation requirements for products and processes.
• Should be able to plan and execute assay verification and validation studies
• The 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 is required but advanced degreed candidates and those with sufficient directly relevant experience are strongly preferred.
• The technical focus should be on 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 are 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 are a plus
• Should be knowledgeable about FDA and other external regulatory agency requirements 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

Job Type: Contract

Salary: $42.50 - $50.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Newark, DE 19702: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Please provide your alternate email address.

Education:

• Bachelor's (Required)

Work Location: One location

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