POSITION SUMMARY

Responsible for developing, characterizing and validating manufacturing processes to produce biochemical assay plates and related consumables.

DUTIES AND RESPONSIBILITIES:

* Review existing manufacturing processes to determine if changes are needed to improve quality and quantity of products, reduce any variations between lots produced and expand product portfolio.

* Make recommendations to manager to improve/enhance processes as needed.

* Design and conduct process experiments on manufacturing and pilot scale equipment to determine if/how changes affect product(s) properties.

* In accordance with standard operating procedures, provide documentation of all experimental results and present findings to manager and other appropriate staff.

* Specific duties may vary depending upon departmental requirements.

EXPERIENCE AND QUALIFICATIONS
* Bachelor's degree in chemical/biochemical engineering or related field.

* Minimum of one year of relevant experience preferred.

KNOWLEDGE, SKILLS AND ABILITIES

* Knowledge of process development techniques (such as process optimization, process control, design of experiments) and statistical analysis.

* Strong analytical and problem solving skills.
* Basic knowledge of industry-related quality standards such as GMP and ISO 9001 is preferred. * Ability to work in a technically challenging, team-oriented environment. * Ability to move project tasks forward in an orderly and structured fashion. * Excellent oral, written communication and interpersonal skills. * Proficiency with the MS Office Suite. * Knowledge of coating techniques, fluid dispensing, drying/desiccation techniques and protein stabilization is preferred. * Ability to multi-task and work productively in a demanding research environment with changing priorities.

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize manufacturing and laboratory equipment, and move about the office and manufacturing floor.

WORK ENVIRONMENT

This position will spend time in a Clean Room environment.