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 .
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.
The Role:
Responsibilities:
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 contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team.
Required Qualifications:
BS / BA in Chemical/ Biological Engineering or Life Sciences or Associates Degree in Science or related field with 1+ years of industry experience or H.S. diploma with 2+ industry experience
Experience in maintaining detailed records and ability to assist in document revisions
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, #GetStuffDone – 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:
BioWork Certification or related type certifications are a plus along with technical understanding of a biotech manufacturing facility
Knowledge of cell growth operations and technique
Experience with single-use technologies
Understanding of FDA regulations
Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
Ability to clearly define events and associated process conditions during nonconformance or safety escalation efforts
Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
Work Conditions
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25lbs
This is an on-site role working in a cGMP regulated manufacturing facility
On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
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Category Sanford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
