Group Leader, Purification Process Development

Details: At Agensys, we're changing tomorrow by moving oncology forward. We've developed a pipeline of novel therapeutic fully human monoclonal antibodies (MAbs) to treat solid tumors based on our own proprietary targets. We have discovered and validated a portfolio of clinically relevant targets in 14 different cancer types. Our pipeline includes therapeutic MAbs to multiple cancer indications that are at different stages of clinical and pre-clinical development. Our parent company, Astellas Pharma US helps us shine. Together we are the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, this is the place for you. Astellas, and our Agensys subsidiary, offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. To continue to change tomorrow, Astellas/Agensys must recruit the best and brightest in the industry Come, shine with us! The successful candidate will play a key role in developing, characterizing, validating, and implementing monoclonal antibody purification processes from laboratory to pilot scale. The scientist will apply engineering and biological expertise to collaboratively develop and optimize purification processes suitable for cGMP manufacturing, and will interact with the teams within Process Development as well as collaborate with members from Manufacturing, Quality Control, Quality Assurance, and the Biotechnology Labs of Astellas in Japan. The scientist will also be responsible for new technology development and process optimization as it benefits Astellas current and future purification platforms. Essential responsibilities include but are not limited to: •Design, develop, and implement recombinant protein purification and recovery processes from laboratory to pilot scale using mammalian cells•Serve as a technical expert in protein purification within the organization and provide support to the equipment and documentation requirements of GMP manufacturing suites and development laboratory •Work with Manufacturing and assist for technology transfer to cGMP manufacturing, provide technical support/ and support troubleshooting of existing processes.•Work both independently and in collaboration with the Purification Process Development team and ensure that corporate objectives are met.•Write and review documentation to support regulatory filings•Generate, analyze, and report results of experiments and present at meetings within Agensys and Astellas.•Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with >5 years of relevant experience in the pharmaceutical /biotechnology industries.•Knowledge of the design, optimization and scale-up of purification processes is a necessity. Direct experience with purification process development and process transfer for clinical or commercial manufacturing of biopharmaceutical product(s) highly preferred.•Hands-on experience with protein purification unit operations such as centrifugation, clarification, precipitation, chromatography and ultrafiltration.•Knowledge of protein biochemistry and competence in routine protein analytical characterization tools such as HPLC, electrophoresis, and spectrophotometry is also required.•Process validation and cGMP experience is desirable.•Supervisory experience preferred. •Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team. •cb*

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