Formulation Chemist

1)5 + years of experience working in industry
2) Medical Device experience
3)Chemistry background with experience in LCMS, Mass Spec, formulations
4)Biological material experience

This is a hands-on scientific contract position in the Clinical Diagnostics R&D group with responsibilities focused on technology transfer to manufacturing. The ideal candidate will have an extensive background developing, scaling, and transferring manufacturing processes for complex chemistry's and reagents, particularly components of in-vitro diagnostic assays, such as calibrators, controls, and related formulations. Key responsibilities include evaluating assay kit design, developing and validating formulation and test methods required to build product to specifications. The incumbent will thrive in a fast paced, entrepreneurial culture.

* Work closely with the assay R&D team during the product development life cycle to develop and evaluate specifications, formulation methods, and test methods for consumable chemistry components of diagnostic assay kits.
* Prepare calibrators and controls from biological matrices and develop robust, reproducible calibrator value assignment methods.
* Develop quality control test methods for all formulations and kit components.
* Transfer procedures from R&D to manufacturing and train operators as required.
* Ensure that all design documentation and test methods for all products are complete and compliant with the applicable quality and regulatory requirements.
* Build and test initial prototype kit components.

Skills and Experience Required:

* A minimum of 5 years in a role supporting consumable chemistry manufacturing.
* Expertise in developing and scaling-up chemical formulation methods.
* Experience with handling standards for biological matrices in a BSL-2 laboratory.
* Extensive knowledge of manufacturing process development and validation.
* Familiar with medical device product development, preferably in an FDA registered, ISO 13485 certified environment.
* Excellent communication and interpersonal skills and the ability to work closely with cross-functional teams in a fast-paced environment.

Education Required:

* Minimum of bachelor's degree in a scientific discipline such as chemistry or biochemistry, advanced degree preferred.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.