Sr. Bioprocess Associate

Astellas • South San Francisco, CA

8d • Onsite

About The Position

The Senior Associate, Technical Development Operations participates in upstream and downstream areas of AAV development and production within process development and the pilot plant for gene therapy programs and processes. The position is based in South San Francisco, California, and requires on-site work. The role involves executing process development experiments and production of non-clinical material, operating production equipment, maintaining controlled records, contributing to process improvements, and assisting with the evaluation and incorporation of new technologies. Work outside normal business hours, overtime, and/or weekends may be required.

Requirements

• Bachelor's degree with at least 5 years of laboratory experience, or a master's degree with at least 3 years of laboratory experience.
• Proficiency with upstream and/or downstream bioprocessing unit operations, such as cell culture, harvest, tangential flow filtration, or column chromatography.
• Working experience developing SOPs or batch records.
• Ability to maintain accurate records and effectively manage multiple projects.
• Ability to work productively in a collaborative, cross-functional team with internal and external partners across scientific disciplines.
• Excellent organizational, written, and oral communication skills to convey technical information clearly to diverse audiences.
• Ability to communicate effectively and work independently as well as in a team.
• Experience maintaining detailed records and assisting with document revisions.
• Strong computer skills, including Microsoft Word, Excel, and PowerPoint.
• Effective problem-solving skills.
• Availability to work outside 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 in biotechnology or pharmaceutical companies.
• Technical understanding of a biotechnology manufacturing facility.
• Experience with single-use technologies.
• Ability to multitask, adapt, and thrive in a fast-paced environment, and handle uncertainty and changing priorities.

Responsibilities

• Perform operations in accordance with internal policies and other requirements.
• Enter clear, legible, and concise data in batch records, logbooks, and other controlled forms.
• Maintain close attention to detail throughout process execution.
• Inspect, set up, operate, process with, and clean production equipment.
• Execute corrective measures to address issues in a timely manner.
• Attend safety meetings, follow safety procedures, and maintain a safe work environment for self and colleagues.
• Contribute to process improvement plans and help drive them to completion.
• Work collaboratively and positively with a team to accomplish goals.
• Execute process development experiments according to defined experimental plans.
• Oversee and execute production of non-clinical material.
• Assist in evaluating and incorporating new technologies.
• Perform other duties as assigned.

Benefits

• Medical, dental, and vision insurance.
• Paid time off options, including vacation and sick time, plus national holidays and a year-end shutdown.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior