Process Development Engineer I & II
As one of the world's foremost providers of premium protein therapies, we not only save lives, but also improve the quality of life for people everywhere. If you are a professional who shares our passion for making a difference, let us make a positive difference in your career. Talecris Biotherapeutics has the following opportunity at our Clayton, NC facility: Process Development Engineer RESPONSIBILITIES-Work in a leadership function within the Process Development and Technology Department.-Plan and carry out scientific/engineering and technical projects in order to evaluate, develop and scale-up processes for plasma-derived proteins and recombinant proteins.-Perform activities such as the development and transfer of unit operations (fermentation, inclusion body recovery, microporous filtration, ultrafiltration, diafiltration, nanofiltration, chromatography, centrifugation, enzymatic conversion, lyophilization), process analysis, technical support, transfer and optimization.-Design, plan and conduct experiments. -Coordinate projects and direct project teams.-Plan and execute process transfer projects. -Contribute to development projects, technologies, publications, intellectual property or trade secrets. -Prepare appropriate technical reports. -Align development activities with team goals.-Mentor peers/colleagues in areas of expertise. -Identify and implement new technologies to continually improve processes. -Review scientific documents for accuracy and completeness. -Write technical documents and present data. Requirements: -Degree in Chemical Engineering or Biochemical Engineering (PhD with 2 years' experience; MS with 9 years' experience; BS with 12 years' experience).-Experience in technology process transfer and process development.-Demonstrated problem-solving skills. -Working knowledge of design of experiments methodology, unit operations, process analysis, optimization, transfer and troubleshooting.-Good understanding of the cGMP and FDA regulations. -Proven knowledge of documentation systems (BPRs, Validation Protocols, SOPs, CSRs, Expense Budget, Work Order, Purchasing Systems). -Ability to interact and collaborate with other departments (Regulatory Affairs, QA, Engineering, Maintenance, Safety, Validation, Production Planning, Accounting, external Regulatory Authorities). Interested candidates should go to www.talecris.com and apply to position 2100. No agency calls please. Talecris offers a competitive salary and benefit package including 401(k) vesting day one with company match, management bonus and profit sharing. All benefits take effect day one of employment. Recently voted to the Companies That Care, Talecris is proud of its work, life, balance programs and its generous tuition reimbursement program. We have the expertise, resources and established business infrastructure to develop, manufacture and market biotechnology products internationally. An Equal Opporutnity Employer M/F/DV, Talecris Biotherapeutics is committed to enhancing and manufacturing cultural diversity within our work environment.
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