What are the responsibilities and job description for the Associate II, Upstream Manufacturing position at ASTELLAS?
Associate II, Upstream Manufacturing
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
The Associate II, Upstream Manufacturing, will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, and validation protocol execution support. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.
- Perform all manufacturing operations under cGMP/ISO requirements
- Display understanding of Upstream process theory (e.g., incubation, expansion, cell growth, harvest) equipment operation, and aseptic processing
- Assist with the installation, commissioning, and validation of equipment within single use facility
- Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required
- Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process
- Maintain a high level of quality and compliance with regards to all aspects of manufacturing
- Assist/write SOPs (standard operating procedures), batch records, and other GMP documentation
- Display ability to identify and escalate potential GMP issues, as required
- Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
- Assist in the evaluation and incorporation of new technologies
The Associate II, Upstream Manufacturing, will typically report to the Supervisor or Sr Supervisor, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.
