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Astellas Pharma Associate II, Upstream Manufacturing in Sanford, North Carolina

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

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

Reporting to the Senior Supervisor, Upstream Manufacturing, this specialist role will be a key contributor to manufacturing readiness and future operational output of the Sanford, North Carolina Gene Therapy manufacturing facility. The Manufacturing Associate role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness in 2023. This includes 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.

Primary Responsibilities

  • Perform all manufacturing operations under cGMP/ISO requirements

  • Display understanding of Upstream process theory (cell growth, transfection, harvest), equipment operation (bioreactors, incubators, tube welders/sealers), 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

  • Set up equipment/machines for proper operation, including installation of consumables and disassembly of equipment and parts required for upstream operations

  • 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

  • Execute corrective measures addressing any issues in a timely manner

  • Assists/writes SOPs (Standard Operating Procedures), batch records, and other GMP documentation

  • 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

  • Assists/writes SOPs (Standard Operating Procedures), batch records, and other GMP documentation

  • Assist in the evaluation and incorporation of new technologies

  • Other duties as assigned

About you

Must Have/Required

  • BS in Science or Engineering or equivalent experience

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

  • 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

  • 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

May Have/Preferred

  • Associate I: 0-2 years of experience working in a GMP manufacturing environment -- applicable certifications are encouraged with no industry work force experience

  • Associate II: 2+ years of experience working in a GMP manufacturing environment

  • Associate III: 4+ years of experience working in a GMP manufacturing environment

  • Senior Associate: 6+ years of experience working a GMP manufacturing environment in upstream operations

  • Technical understanding of a biotech manufacturing facility

  • Knowledge of cell culture operations

  • 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

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 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

Category Manufacturing

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

EOE including Disability/Protected Veterans

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