Senior Manager, DR/BC, IT QA, and Process Improvement

Details: Astellas is 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, Astellas is the place where you can shine. We 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. Come, shine with us!Astellas is announcing a Senior Manager, DR/BC, IT QA, and Process Improvement opportunity in our Northbrook, IL location.This key leadership position is responsible for the IT Disaster Recovery/Business Continuity/Crisis Management, IT QA, and for process improvement projects within IT. Own and implement Disaster Recovery processes and strategies to ensure the security and integrity of data, data systems, and data networks across the organization. This includes re-establishing servers, applications, databases and operating systems in the event of a disruption, whether minor or catastrophic.Responsible for the Disaster Recovery Plan and overall strategy along with executing the disaster recovery plans and tests for Astellas's applications. Develop and mature the IT Disaster Recovery planning processes, including the strategy, approach, plans, and resources.Develop, maintain, and lead Crisis Management planning and execution.Facilitate the cross-functional activities necessary to conduct Business Impact Assessments for all applications with IT business partners and third-party vendors.Work with internal IT teams and PMO to ensure that policies, procedures, and tools are integrated into Disaster Recovery processes. Manage the creation of program status communications to internal management and external stakeholders regarding the status of the IT disaster recovery program, including annual reporting, audit report responses and customer requests.Provide PMO support with quality assurance of deliverables and overall support.Drive and own process improvement initiatives utilizing best practice process methodologies.Bachelors Degree in Computer Science or Business, or equivalent experience required. Masters Degree preferredMinimum 10+ years of related experience required, pharmaceutical industry preferredMust have excellent interpersonal and communications skills in order to effectively relate to internal and external professionals Vendor management of external Disaster Recovery service providersAt least two years experience in Business Continuity Management, QA, and Process Improvement MethodologiesExperience in defining, implementing and enforcing risk-based standards, processes and procedures for responding to disruptions in business or IT operationsProven competency in executing large projects, on time and within budget, with business and IT personnelProven ability to work under stressful conditions, such as business-related crises•cb*

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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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