Process Development Associate

Job description

Location- Lexington, MA Duration- 9m +++ Development Engineer / Associate (Contract) – Clinical Drug Product Manufacturing Sciences (CDPMS) The Development Engineer / Associate – CDPMS will assist drug product tech transfer teams with project management support. Project management support will include scheduling, resource planning, and project task tracking. A candidate with the right experience would have the opportunity to lead a drug product tech transfer team. The primary responsibility of the candidate will be to perform project management activities to manage the external manufacture of clinical trial materials. In addition, the candidate will coordinate external research projects such as compatibility and filter validation studies. Additional responsibilities will include performing drug product process development studies in collaboration with drug product manufacturing and formulation development teams. The Development Engineer / Associate will also analyze experimental data, document results and conclusions in technical reports, and assist Senior Staff with drug product tech transfer management projects. This will be a visible and hands on role with opportunities to contribute to multiple clinical stage programs. In this role, the Development Engineer / Associate must be able to work independently and be self-motivated. The candidate must manage time efficiently to balance multiple projects and priorities. Excellent organization and communication (oral and written) skills are required. Qualifications • BS/MS in degree in chemical, biochemical, biomedical engineering, chemistry or related field • 3-6 years industry experience in formulation and/or drug product process development • Experience in supporting tech transfer projects to contract research and/or manufacturing organizations • Project management experience including time and resource scheduling • Experience in a GMP environment or GLP laboratory is preferred • Experience with Microsoft Project, Vizio, and advanced Excel spreadsheets is preferred • Experience managing outsourced research projects is a plus • Knowledge of statistical design of experiments is a plus All your information will be kept confidential according to EEO guidelines. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.