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Astellas Pharma Associate I, Manufacturing Upstream in South San Francisco, California

Why Work for Us

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 Right. If you’d like to be a part of this important mission, please apply to join our team.

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.astellasgenetherpaies.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 into the Supervisor, Upstream Manufacturing, this role will be a contributing participant to the upstream operations at Astellas Gene Therapies. The Associate, Manufacturing will follow defined tasks in the Manufacturing department and will effectively contribute to a team that is ultimately responsible for the processes and manufacturing at Astellas Gene Therapies. The Associate, Manufacturing will be present in the production process, meet deadlines, and be an active participant in issue reporting and resolution. This position is located in South San Francisco.

Primary Responsibilities

  • Perform all manufacturing operations under cGMP/ISO requirements.

  • Follow all safety procedures as defined, maintain a safe work environment for both self and colleagues, and report safety incidents and potential safety issues in a timely manner.

  • Upstream operations (cell growth, harvest), equipment operation (bioreactors, incubators, tube welders/sealers), and aseptic processing.

  • Performs aseptic work inside a hood.

  • Adhere to and perform all documentation to provide the proper accountability and traceability of components used and operations taken.

  • 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. Adheres to current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations.

  • Maintain a high level of quality and compliance with regard 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.

  • Records and helps review documents that are required to maintain documentation and compliance with cGMP.

  • Available to work various shifts (e.g., Days, Holidays) ad hoc as needed and as directed by the production schedule.

About you

Must Have/Required

  • Associate’s or Bachelor’s degree in Science or Engineering or equivalent industry experience and 1+ years working in a GMP manufacturing or regulated laboratory environment.

  • Proven experience in maintaining detailed records and ability to assist in document revisions. Highly capable of keeping accurate records.

  • Ability to contribute to process improvement plans and help drive to completion.

  • Strong understanding of cGMPs as related to Drug Substance operations.

  • Understands the basic aseptic behaviors required for hood work.

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

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

  • Effective problem-solving skills.

  • 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

  • Technical understanding of a biotech manufacturing facility.

  • Knowledge of cell culture and/or protein purification.

  • Experience with single-use technologies.

  • 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 changing priorities.

  • Knowledge of aseptic technique, cGMP, or FDA regulations.

  • Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders.

  • Familiar with using ERP systems such as SAP, Oracle, etc.

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 Gene Therapy Research & Technical Operations

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

EOE including Disability/Protected Veterans

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