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Development Associate III, Nucleic Acid Technology - United States
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Posted on : 18 May 2017
- This Development Associate III position will contribute to the optimization of manufacturing processes for our company's bio therapeutic candidates and to the development of nucleic acid analytical/characterization methods.
- This position will be involved in development efforts ranging from discovery to early-stage clinical manufacture.
- This role will require collaboration with internal departments and outside partners to support the manufacture of nucleic acid-based therapeutics.
- Support the development and manufacture of nucleic acid drug candidates from preclinical to early-stage clinical, with emphasis on nucleic acid formulation.
- Execute analytical method development and testing to support nucleic acid process development and formulation.
- Facilitate interactions with external partners and CROs in assay development, assay transfer, sample analysis and troubleshooting.
- Serve as a technical expert on lab instrumentation, software and/or assay procedures.
- Document study results in technical reports.
- Support group objectives associated with technology transfers and regulatory filings.
- 5+ years’ relevant work experience in the biopharmaceutical industry is required.
- Experience in biophysical, chemical, and/or physicochemical analytical methods for nucleic acid formulations characterization is required.
- Experience developing assays to support biotherapeutic process development is preferred.
- Experience working with nucleic acids and in a sterile/RNase-free environment is preferred.
- Knowledge of nucleic acid delivery technologies, including nanoparticulate and conjugate systems, is preferred.
- Experience coordinating testing and method development at CROs is preferred.
- Knowledge of the CMC/regulatory environment as related to nucleic acid therapeutics is preferred.
- The ability to process, interpret, compile data and generate technical reports is required.
- A high level of organization and the ability to handle multiple tasks/projects simultaneously are required.
- Good written and oral communication skills are required.
- Strong inter-personal skills and a willingness to collaborate with colleagues at the bench and on project teams are required.
MS in relevant engineering, chemistry, or biological science field with a minimum of 3 years of experience in a pharmaceutical or biotechnology setting, or BS degree in relevant field with a minimum of 5 years of experience in a pharmaceutical or biotechnology setting.
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas