Job Information:
Manufacturing Associate IV, Downstream Lead – A
Company
Overview
Launched in April 2005, Astellas was formed by the historical merger
of Japan's third and fifth largest pharmaceutical companies - Yamanouchi,
founded in 1923, and Fujisawa, founded in 1894. With an unrelenting
commitment to R&D as a value-creating core of its business, Astellas
is consolidated around complementary strengths from Yamanouchi and
Fujisawa. Astellas blends the talents, resources and passions of two
highly successful firms - Yamanouchi and Fujisawa. In the U.S., our
five-year plan calls for intense focus on five key therapeutic areas
- Cardiology, Dermatology, Immunology, Infectious Disease and Urology
- which will help lead to becoming a globally competitive company
respected for our knowledge and innovation in established franchises.
Job Description
Full Job Title: Job Information: Manufacturing Associate IV, Downstream
Lead - Agensys, Santa Monica
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 Manufacturing Associate
IV, Downstream Lead's essential tasks are as follows, but not limited
to:
1. Perform a variety of clinical manufacturing activities, including
operation of Chromatography skids, column packing, clarification,
and related purification steps.
2. Accurately record process documentation
3. Troubleshoot process equipment or issues as needed
4. Develop, review or revise process documents and SOP (Standard Operating
Procedures) to support the MFG operations
5. Comply with current Good Manufacturing Practices (cGMP), safety
regulations, SOPs, and Batch Production Records
6. Assist with validation protocols, IO/OQ/PQ, as needed
7. Assist with observations or deviation investigations as needed
8. Experience with Chromatography skids, Ultrafiltration / diafiltration,
and Filling operations
Additional
Lead responsibilities are as follows, but not limited to:
1. Lead investigation teams
2. Review Batch Production Records
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