Biopharma Manufacturing Associate II

** Biopharma Manufacturing Associate II*
* ** About Astellas*
* Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at

** Are you driven to make a real difference in the lives of patients?*
* We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

** Purpose & Scope*
* The Biopharma Manufacturing Associate II 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.

** Role and Responsibilities*
* + Perform all manufacturing operations under cGMP/ISO requirements

+ Display understanding of Upstream process theory (e.g., cell thawing, passages, and harvesting) 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

** Required Qualifications*
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* Education:

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* + BS / BA in Chemical/ Biological Engineering or Life Sciences or Associate's Degree in science or related field with 1+ years of industry experience.

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* Experience:

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* + Experience in maintaining detailed records and ability to assist in document revisions

+ Experience in cell culture with excellent aseptic technique

+ Strong skill on biological laboratory math

+ Understanding of cGMPS as related to commercial and clinical operations

+ Strong communicator with ability to work effectively both independently and as part of a team - Developing problem-solving skills

+ Strong computer skills including MS Office (Word, Excel) and proven ability to establish and maintain effective working relationships with team members and managers

+ Models our Core Values:
Be Bold, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

+ Will support and demonstrate quality standards to ensure data of highest quality and will be expected to perform other duties and/or special projects, as assigned

** Preferred Qualifications*
* + Bio Work Certification or related type certifications are a plus along with technical understanding of a biotech manufacturing facility

+ Knowledge of upstream process and aseptic technique

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Experience with single-use technologies

+ Understanding of FDA regulations

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Experience with continuous improvement platforms and history of identifying changes with…