Senior Bioprocess Associate

Astellas PharmaBurlingame, CA
$82,880 - $118,400Onsite

About The Position

The Senior Associate, Technical Development Operations will participate in upstream and downstream areas of AAV development and production within process development and the pilot plant for gene therapy programs and processes. This position is in South San Francisco, CA.

Requirements

  • Bachelor's degree with 5+ years lab experience or Master's degree with 3+ years lab experience.
  • Exhibit proficiency with upstream and/or downstream bioprocessing unit operations (i.e., Cell Culture, Harvest, Tangential Flow Filtration, Column Chromatography)
  • Working experience in the development of SOPs or batch records.
  • Ability to maintain accurate records and effectively manage multiple projects
  • Ability to work productively in a collaborative and cross functional team environment with internal and external partners across multiple scientific disciplines
  • Excellent organizational, written, and oral communication skills to convey technical information clearly to diverse audiences.
  • Strong communicator with ability to work effectively both independently and as part of a team
  • Demonstrated experience in maintaining detailed records and ability to assist in document revisions
  • Strong computer skills including MS Office (Word, Excel, PowerPoint)
  • Effective problem-solving skills
  • Available to work outside of normal business hours and/or weekends as required

Nice To Haves

  • Experience in process development of cell culture and/or protein purification processes
  • Experience working with viruses, especially Adeno-Associated Virus (AAV)
  • Experience working in biotech and pharma
  • Technical understanding of a biotech manufacturing facility
  • Experience with single-use technologies
  • 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

Responsibilities

  • Perform all operations as directed per internal policies and other requirements.
  • Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in the process
  • Maintain a high level of attention to detail with regards to all aspects of process execution
  • Operate production equipment, including inspection, set up, processing, and cleaning
  • Execute corrective measures addressing any issues in a timely manner
  • Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues. Execute corrective measures addressing any issues in a timely manner
  • Ability to contribute to process improvement plans and help drive to completion
  • Conduct operations in a collaborative, team environment with a positive attitude to accomplish goals
  • Available to work outside of normal business hours and/or overtime as required
  • Execute process development experiments following defined experimental plans
  • Oversee and execute production of non-clinical material
  • Assist in the evaluation and incorporation of new technologies
  • Other duties as assigned

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
  • Company fleet vehicle for eligible positions
  • Referral bonus program
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