Manufacturing Associate I

　　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 .

　　Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

　　AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

　　Astellas is announcing a Manufacturing Associate I opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

　　Purpose:

　　The Manufacturing Associate I role will be a 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 is an entry level role in an operations environment. This includes equipment testing, SOP/batch record collaboration, 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.

　　Essential Job Responsibilities:

　　Perform all manufacturing operations under cGMP/ISO requirements

　　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; may support additional operational projects as assigned

　　Maintain a high level of quality and compliance with regards to all aspects of manufacturing

　　Maintain 100% on-time training completion in learning management systems, completing downstream on the job training curricula as required

　　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

　　Quantitative Dimensions:

　　The Manufacturing Associate I 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.

　　Organizational Context:

　　The Manufacturing Associate I 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 and Cell Therapies and the Astellas organization.

　　Qualifications:

　　Required:

　　0-2 years of experience working in a GMP manufacturing environment – applicable certifications are encouraged with no industry experience

　　Strong skill on biological laboratory math

　　Knowledge of aseptic technique

　　Strong communicator with ability to work effectively both independently and as part of a team along with capacity to maintain detailed records and ability to assist in document revisions

　　Proven ability to establish and maintain effective working relationships with team members and managers.

　　Will support and demonstrate quality standards to ensure data of highest quality

　　Strong communicator with ability to work effectively both independently and as part of a team

　　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 be expected to perform other duties and/or special projects, as assigned

　　Preferred:

　　BioWork Certification or related certifications along with technical understanding of a biotech manufacturing facility are a plus

　　Understanding of cGMPS as related to commercial and clinical operations

　　Capacity to learn an ability to develop technical proficiency towards the use of general MFG equipment

　　Experience with single-use technologies and understanding of FDA regulations

　　Strong computer skills including MS Office (Word, Excel)

　　Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency

　　Ability to support general investigations and CAPA execution

　　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

　　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

　　#LI-TD

　　Category Massachusetts TC

　　Astellas is committed to equality of opportunity in all aspects of employment.

　　EOE including Disability/Protected Veterans