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

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply – for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

The Associate II, Downstream 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.

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

The Associate II, Downstream 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.

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 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 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

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

EOE including Disability/Protected Veterans