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 III, 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, validation protocol execution support, as well as cross site tech transfer collaboration. 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 while displaying a proficient understanding of upstream process theory (e.g., incubation, expansion, transfection, harvest) equipment operation, and aseptic processing

  • Assist with the installation, commissioning, and validation of equipment within single use facility

  • Adhere to manufacturing GMP documentation guidance (e.g., standard operating procedures) with a proven ability to identify clarifications / updates as well as assist with document updates / generation when required

  • Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process and maintain a high level of quality and compliance with regards to all aspects of manufacturing in both personal actions as well as through the training of other manufacturing associates

  • Ability to identify and escalate process non-conformances based on process guidance documents, specified operating limits, and performance metrics tracking

  • Able to contribute cross departmentally through downstream operation support assignments that fall outside of upstream responsibilities

  • Often assigned in a support role to internal and cross-functional project teams

  • Lead the completion of routine non-process operations including, but not limited to, preventative maintenance work order execution and safety walkthrough audits

  • Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules

Required Qualifications

  • BS / BA in Chemical/ Biological Engineering or Life Sciences with 2+ year of applicable industry experience or Associates Degree in Science with 3+ years of industry experience or H.S. diploma with 4+ years of industry experience

  • Understanding of cGMPS as related to commercial and clinical operations

  • Experience in maintaining detailed records and ability to assist in document revisions

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

  • Effective problem-solving skills

  • Strong computer skills including MS Office (Word, Excel)

  • 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

  • Strong communicator with the ability to work independently and closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work

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

Preferred

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

  • Proficient understanding of cell growth operations and technique

  • Experienced in Startup of a new facility

  • 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 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

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