Aseptic Process Scientist


Kelly Scientific Resources


Posted Under: Durham, North Carolina jobs in Other; Other jobs in zipcode 27701
Posted On: 2020-02-15 00:00:00

Aseptic Process Engineer (Direct Hire) - Durham, NCKelly Scientific is seeking candidates for a direct-hire--Aseptic Process Scientist/Engineer role we have with a very well-esteemed client in Durham, NC!The Aseptic Scientist/Engineer--is required to support the development of sterile and aseptic biopharmaceutical manufacturing processes from Phase I through--commercial manufacturing. This role will be responsible for--drug substance and drug product process development,--process optimization, technology transfer, manufacturing, quality, validation and regulatory filings. The Aseptic Scientist will work with the contract manufacturer--to proactively identify and mitigate process risks.-----*Must Have**:-- BS/MS or Advanced degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences or equivalent AND--2--years of relevant pharmaceutical/biotechnology experience. Experience with sterile or aseptic processing, process development, validation, pilot plants and/or GMP manufacturing, and statistical process control is required.You will: Work on process development for the tissue-based regenerative medicine program, including development of viability and potency assays, shipping containers, transport studies and cryopreservation. Partner with the contract manufacturer to implement process improvements and manage risks and mitigation strategies Assist in troubleshooting drug substance and drug product process-related issues, reviewing manufacturing investigations and ensuring appropriate CAPAs are implemented to prevent recurrence of process-related failures. Coordinate with other functions as appropriate to produce material for clinical and non-clinical studies. In collaboration with the Quality Assurance department, ensure that all laboratory, pilot scale and commercial manufacturing activities are executed in compliance with the appropriate regulations and cGMP where applicable. Ensure proper communication and reporting--to internal stakeholders.Qualifications: BS/MS or Advanced degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences or equivalent, with a minimum of 2--years of relevant pharmaceutical/biotechnology experience. Experience with sterile or aseptic processing, process development, validation, pilot plants and/or GMP manufacturing, and statistical process control is required. Experience with cell or tissue culture is preferred.. Experience with project management is a plus. Excellent skills required in Excel, Word, PowerPoint and Adobe Acrobat; experience in Minitab or equivalent statistical program preferred. Knowledge of ICH, FDA, EMA regulations focused on process development. Quality Management Systems knowledge is a plus. Excellent written and oral communication skills. Ability to execute job duties with minimal oversight.Why Kelly--?With Kelly, you'll have access to some of the world's highest regarded scientific organizations-providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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