Medasource
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Scientist I, GMP Analytical Team
Role Description:
The GMP Analytical Team at our client in Durham is seeking a colleague who will work on the development, qualification/validation and execution of analytical and biophysical assays to support the characterization of novel protein and RNA vaccine products. She/he will provide comprehensive analytical support from the early clone selection stage to the final purification stage of the product. The assays will be suitable for the characterization of quality attributes during downstream process development and for release and stability testing. The successful candidate will have expertise in a broad range of analytical and biophysical techniques, e.g., advance liquid chromatography methods, ligand binding and cell based assays. The ability to execute and document analytical methods in a regulatory compliant manner is essential.
Responsibilities:
· Lead and participate in the development and execution of robust and reliable analytical assays for the characterization of vaccine quality attributes using a range of potential analytical platforms.
- Support optimization of methods during process development by providing key analytical information regarding the quality of the potential vaccine product.
- Perform data analysis and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
- Lead and assist in the development of new methodologies in analytical/biophysical and antigenicity testing of vaccine products.
- Operate in a GMP regulated environment, follow departmental SOPs and Regulatory guidelines.
Qualifications:
· BS/MS with 6+ years of relevant industry experience with a focus on analytical assay development.
· Knowledge and hands-on experience developing analytical assays utilizing various platforms (experience in advanced liquid chromatography and ligand binding assays is expected; experience in CGE, DLS, ELISA and cell based assays is a plus).
· Demonstrated ability in troubleshooting complex analytical problems.
· Proven ability to generate high quality data and documentation within challenging time lines.
· Excellent oral and written communication skills, attention to detail and collaboration skills.
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
JO-2409-150562