Biological\/Chemical Scientist\/Engineer 1

Description:

The successful candidate must have knowledge &/or experience in the development of chemical/biochemical processes. In addition to understanding process design considerations the candidate must be assist in the validation of associated equipment and process steps including helping to develop IQ, OQ and PQ validation protocols and then executing such protocols. Additionally, it will be expected that the successful candidate will have the ability to drive cross-functional PFMEA reviews and participate in process hazard reviews.

A person in this role will also be expected to assist in the transfer of new products into these facilities and to establish the operating instructions to guide formulation, filling, packaging and testing of products produced with these facilities.

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