Direct Hire-Process Validation/Development Scientist

Process Validation/Development ScientistKelly Scientific Resources is looking to fill a Direct placement position for a Process Validation/Development Scientist in Malvern, PA. This client is known for highly competitive salaries and benefits, including health insurance plans, employee savings plans and other benefits. The incumbent will author process validation/development protocols and reports to support the development and validation of the AA4500 fermentation and purification manufacturing processes. Design and execute experiments to support the development, optimization and validation of the AA4500 API manufacturing process. Provide technical support and guidance for the successful development, scale-up, technology transfer and manufacture of AA4500 to clinical and commercial production scales.Responsibilities will include but are not limited to the following:- As applicable, execute experiments and author documentation to support fermentation and purification process validation, development and scale-up initiatives.-Author, review, and execute protocols, reports and SOPs associated with laboratory policies and procedures.-Develop purification processes for recombinant proteins. -Provide technical support as needed for secondary manufacture of AA4500, cleaning, shipping and other development, analytical or validation efforts as required. -As required, troubleshoot fermentation and purification processes and equipment and assist GMP operations with resolution of atypical events and/or manufacturing non-conformances.-Utilize technical knowledge to assist with continuous improvement initiatives by identification of novel production equipment, technologies and test methods.-Ensure laboratory operations are established and maintained in compliance with all applicable regulations, guidelines and safety polices and procedures.-Maintain individual training records as appropriate.Education and Experience:- BS/MS Biological Sciences, Biotechnology or Biochemical Engineering.-Minimum 3-5 years working in biopharmaceutical process development and validation laboratories, technology development and technology transfer.-Strong background in microbial fermentation, purification and process scale-up required. -Experience in process development of recombinant proteins.-Experience working with/supporting commercial and/or clinical manufacturing groups.-Knowledge of process validation practices for biopharmaceutical products, including, but not limited to: identification of critical process parameters and operational ranges; performance of process risk-assessments; author and execution of process validation protocols and reports; development and qualification of small-scale fermentation and chromatography models.Relevant experience to include buffer/media prep, fermentation, column chromatography, TFF, protein formulation and working knowledge of cGMPs.Kelly Scientific Resources is a highly specialized and rapidly expanding business unit of global staffing provider, Kelly Services, Inc. Kelly Scientific Resources leads the world in dedicated scientific and clinical research staffing, operating in 19 countries throughout North America, Europe, and the Pacific Rim. Since its launch in 1995, Kelly Scientific Resources has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. For more information, visit www.kellyscientific.com Learn more about company