Senior Process Development Engineer
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
The successful candidate will be part of the Purification Process Development Department and will be involved in the development of purification processes for antibodies and the generation of antibody-drug-conjugates. DUTIES & RESPONSIBILITIES:
* Development and optimization of purification processes for antibodies
* Development and optimization of conjugation processes of antibody-drug conjugates
* Implement innovative development strategies into existing processes
* Transfer and oversight of purification and conjugation processes to manufacturing sites
* Design and perform process characterization activities for biopharmaceutical manufacturing processes
* Participate in process validation activities of biopharmaceuticals
* Collaborate with internal groups on biologics projects.
* Represent the Process Development Department on various project teams
* Support of regulatory filings
The candidate should preferably hold a Ph.D. degree in biochemical engineering/ biotechnology or closely related fields and possess 5+ years experience in bioprocess development, scale-up and validation, or MS/BS with 10+ years experience. The open position requires hands-on experience in Process Chromatography ranging from small analytical to multi-gram scale and in the conjugation of proteins to drug-linkers using DOE approaches. The candidate should be familiar with cGMPs for biopharmaceuticals and regulatory submissions and show the ability to work well independently as well as a member of a team. Excellent oral and written communication skills are required. Takeda provides equal employment [and affirmative action] opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.
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