June 2, 2010 - Research assistant in Plant-based Protein Production

A research assistant position is available immediately at Fraunhofer USA Center for Molecular Biotechnology in Newark, DE. The Center focuses on the development of vaccines and therapeutics in plant-based protein production systems. Extensive experience in molecular biology (cloning, DNA/RNA purification, PCR, RT-PCR, ELISA, PAGE, Westen-blot) and protein biochemistry is required. Five years of experience in this field is required. Individuals with a Master’s degree in molecular biology, biochemistry or a related discipline are encouraged to apply. Candidates should have good organizational, record keeping and computer skills, and should be able to work well in a team environment.

FhCMB offers competitive salaries and benefit packages and is an equal opportunity employer.

Interested candidates should e-mail their resume or curriculum vitae and a cover letter referencing the position for which they are applying along with the names, e-mail addresses, and phone numbers of three professional references to personnel@fraunhofer-cmb.org.

May 20, 2010 - Regulatory and Clinical Affairs Director

A Regulatory and Clinical Affairs Director position is available immediately at Fraunhofer USA Inc., Center for Molecular Biotechnology (FhCMB) in Newark, DE to direct Regulatory and Clinical Affairs activities for projects focused on progressing protein subunit vaccine candidates through early stage (Phase 1 and 2) clinical trials. FhCMB focuses on plant-based production of proteins for vaccine and therapeutic development and has recently begun operating a pilot-plant for the production of clinical grade material under cGMP. The successful candidate will be responsible for planning, coordinating and preparing regulatory submissions to the FDA, and for interactions with the agency. In addition, the successful candidate will design and plan clinical trials, and will coordinate and provide oversight for the execution of these trials with contract research organizations, and for the analysis of clinical trial data. The successful candidate will work closely with multi-functional groups within FhCMB, including R&D, manufacturing, quality assurance, quality control and project management. Applicants should possess a PhD in a biomedical discipline and/or an MD and should have at least ten years of relevant experience. Applicants should also have an employment history in regulatory and/or clinical affairs positions in the pharmaceutical and/or biotechnology industries. A background in biologics, and preferably in vaccines, is highly desirable. The successful applicant will be highly motivated, have excellent presentation and communication skills, and will be a strong team player.

FhCMB offers competitive salaries and benefit packages and is an equal opportunity employer.

Interested candidates should e-mail their resume or curriculum vitae and a cover letter referencing the position for which they are applying along with the names, e-mail addresses, and phone numbers of three professional references to personnel@fraunhofer-cmb.org.