Massachusetts Jobs

Manufacturing Associate II

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 II opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The 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.

Essential Job Responsibilities:

• Perform all manufacturing operations under cGMP/ISO requirements

• Display understanding of Downstream process theory (e.g., tangential flow filtration, chromatography) 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

Quantitative Dimensions:

The Associate II 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 Associate II 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:

• 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

• 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

• Occasional weekend work

• 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:

• Cell Culture experience a major plus.

• BioWork Certification or related type certification are a plus along with technical understanding of a biotech manufacturing facility

• Knowledge of protein purification 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

Working 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 and Cell Therapies manufacturing facilities (0-5%)

#LI-TD

Category Massachusetts TC

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

EOE including Disability/Protected Veterans