Vacancy has expired
Show me jobs like this one| Job Ref: | hec.1284030 |
| Job Type: | Full Time |
| State: | Ohio (OH) |
| City: | Cleveland |
| Post Code: | Jan 27, 2012 |
| Job Description: |
SironRX Therapeutics is a venture-backed, clinical-stage biotechnology company developing novel therapies for treatment of wound and bone repair. The Product Development Associate will be responsible for managing day-to-day product development related activities. Laboratory responsibilities will include assay development, product stability testing, cell culture, plasmid DNA production and coordinating shipment of clinical trial materials to sites. The preferred candidate will also be able to develop necessary SOPs for the laboratory and participate in developing appropriate QA/QC processes. The Product Development Associate will be responsible for managing and distributing clinical trial materials and may participate in preparing regulatory submissions, which may include safety, efficacy, CMC, and labeling. Expertise in gene therapy, wound healing, and bone repair is a plus. Adaptability and comfort working in a fast-moving, highly dynamic start-up environment are a must. Highly developed interpersonal written and oral communication skills, attention to details, and effective computer skills are required. The successful candidate will be highly organized and capable of working within a team to assure assignments are completed on time. Key responsibilities will include general molecular biology bench work and working with the Director, Product Development to ensure that programs are progressing along projected timelines. In addition, candidates must have flexibility to take on new tasks as they arise within the company. We are looking for self-motivated individuals interested in science and drug development as part of their career development. MINIMUM QUALIFICATIONS: Education, Knowledge, Skills and Abilities The successful candidate at a minimum must have bachelors or master's degree in a science-related discipline. Experience in execution of wound healing and or orthopedic research is preferred. The proper candidate will have strong therapeutic product development experience preferably in the area of assay development and transitioning technologies into early stage clinical trials. Strong technical writing skills are a must and experience working on therapeutic product approvals is preferred. The proper candidate will be a self-starter and willing to work in a dynamic, high-paced start-up environment. Required Length and Type of Experience The successful candidate will have minimum of 2 years experience working at a biotechnology or pharmaceutical company having developed products for clinical trials or 3-5 years experience in an academic research laboratory. Experience in gene therapy, biologics and/or wound healing product development a plus. Must have experience in organizing, summarizing, and communicating scientific results through publication or engagement with teams. Experience with negotiating or managing contracts with contract vendors is a plus. PRINCIPLE DUTIES AND RESPONSIBILITIES: - Utilize cellular and molecular biological techniques such as PCR and RT-PCR, DNA isolation and purification, restriction enzyme digestion, cloning and constructing recombinant plasmids. - Assay development - Conduct directed experiments using histological tissue preparation, staining and analysis, microscopy and image analysis, molecular biology techniques including quantitative PCR and tissue culture on primary cells. - Collect and analyze data, write and update laboratory Standard Operating Procedures (SOPs), research primary literature, assemble research posters and write scientific lab reports. - Compose manuscripts for peer-reviewed publications, chapters for books, reviews of peer publications and grant submissions. - Technical writing including drafting sections of regulatory, clinical or other related documents. - Assist in preparing and managing documentation related to execution of clinical trials or FDA-guided pre-clinical studies. - Liaison between company and contract vendors ensuring that projects are meeting timelines and budgets. - Assist in development of clinical drug product testing, stability, storage and site distribution. - Other tasks as assigned. Requirements |
| Post Date: | 01/28/2012 |
