Associate Scientist-Formulations

Conduct pre-formulation and formulation studies for liquid and lyophilized vaccines adsorbed to aluminum based adjuvants. Coordinate preparation, storage and testing of pre-clinical samples for multiple projects simultaneously. Maintain electronic and physical inventory of pre-clinical and stability samples prepared by FD and coordinate sample submissions to the analytical department (AD) for physicochemical testing or to the Potency Assay Unit (PAU) group for pre-clinical studies in animals. Perform stability and characterization studies for R&D and clinical vaccine samples.

Responsibilites
Develop appropriate assays to characterize the content and the purity of the biological and adjuvant molecules in the liquid and dry presentation
Identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules at the desired storage conditions
Determine primary degradation pathways for biological and adjuvant molecules, including proteins adsorbed to alum and other adjuvants
Utilize appropriate analytical techniques for optimization of formulation and process parameters for liquid or dry vaccine presentation
Provide support to formulate small and large scale lots of liquid, frozen or lyophilized vaccine samples
Provide support to formulate small and large scale lots of liquid, frozen or lyophilized vaccine samples
Run tests and assays such as % moisture content, particle size distribution analysis, SDS-PAGE, Western Blot, ELISA, Bradford and BCA
Help maintain laboratory equipment up-to-date for maintenance and calibration schedules

Technical Skills required:
Knowledge of the following techniques or formulation methods are preferred:
Hands-on experience in the use of freeze-drying equipment, lyo cycle design and problem solving related to lyophilization process
Some knowledge in protein and immunological assays such as ELISA, SDS-PAGE, Western Blot, Southern Blot, protein staining, Bradford, cell based toxin neutralizing assays
Hands-on experience in dry formulation assays such as the Karl Fischer residual moisture content analysis and Differential Scanning Calorimetry
Understanding of biophysical techniques such as Dynamic light scattering, UV-visible and fluorescent spectroscopy
Hands-on and problem solving in analytical methods and equipment


Additional Responsibilities Include:
* Support lead formulation selection by designing and conducting pre-formulation studies to analyze stability, solubility, effects of pH and temperature, and compatibility of vaccine components.
* Develop and characterize parenteral formulations for preclinical and early clinical studies in dry and liquid presentations
* Design and conduct stability studies at various stages of formulation development
* Transfer formulation processes and analytical methods across groups
* Support testing of new drug formulations at various stages of development
* Optimize formulations and characterization assays for late-stage clinical trials.

Documentation
* Ensuring that laboratory notebooks are used to adequately and accurately document technical work and are reviewed and signed for content and intellectual property
* Writing internal reports, technical documentation and other appropriate documents as required
* Work within internal and external quality systems to ensure documentation trails are maintained throughout
* Writing and reviewing of appropriate technical SOPs for use both internally and at CMO and/or CROs

Communication
* To communicate ideas and strategies with colleagues and the Process & Analytical Development Director
* To work closely with colleagues and/or mentors for acquiring direction and reporting progress on assigned projects
* To report progress on a regular basis to the appropriate Process & Analytical Development Director
* To monitor and communicate progress, and highlight delays or potential risks to project timelines
* Present technical data and information to the function as appropriate

Conduct pre-formulation and formulation studies for liquid and lyophilized vaccines absorbed to aluminum based adjuvants. Perform physiochemical and immunological assays required for formulation optimization and physicochemical characterization of a final drug product. Perform stability and characterization studies for R&D and clinical vaccine samples.


The above job description are the must haves per the hiring manager, other responsibilities the person will have depending on experience could be as follows:

* Proficient in protein and immunological assays such as ELISA, SDS-PAGE, Western Blot, Southern Blot, protein staining, Bradford, cell based toxin neutralizing assays
* Hands-on experience in dry formulation assays such as the Karl Fischer residual moisture content analysis and Differential Scanning Calorimetry
* Understanding of biophysical techniques such as Dynamic light scattering, UV-visible and fluorescent spectroscopy
* Hands-on and problem solving in analytical methods and equipment
* Broad knowledge on quality and regulatory requirements such as USP, ICH, GLP/cGMP
* Proven record of technical transfer of assays from early phase to clinical manufacturing or clinical trials.

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.

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