Position Title: Associate I, Technical Development Operations
Work Location:  South San Francisco, CA.
Assignment Duration: 6 Months
Work Schedule: Available to work outside of normal business hours and/or overtime as required (occasional weekend work)
Work Arrangement: This is a lab and office-centric position that requires onsite work.

Position Summary: The associate 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.

Background & Context: This position reports to the Lead, Technical Department Operations in the Technical Development Department within the Astellas Cell and Gene Therapy Research Division.

Key Responsibilities:
• Perform all operations as directed per internal policies and other requirements.
• Execute experiments for cell culture and transfections in shake flasks and various scales of bioreactors
• Maintain seed train cell cultures, from vial thaw through expansions and cell banking
• Perform cell culture harvest operations, ensuring minimal loss of product
• Support downstream purification unit operations (such as chromatography, clarification, tangential flow filtration, sterile filtration, column packing, etc.)
• Operate production equipment, including inspection, set up, processing, and cleaning
Establish operating equipment specifications and improve operational techniques
• 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
• Assist with process development experiments following defined experimental plans for non-GMP supply
• Document preparation and maintenance for process development and research grade AAV production operations
• Maintain digital records of all research production activities using in-house systems and shared digital document repositories.
• Follow laboratory safety procedures.
• Other duties as assigned

Qualifications & Experience: Required
• BS in Life Science or Engineering or equivalent experience
• Associate I: 0-2+ years of experience working in a pharmaceutical/biologics lab or manufacturing environment
• Display understanding of upstream and/or downstream process theory (i.e., Cell Culture, Harvest, Tangential Flow Filtration, Column Chromatography) and equipment operation
• 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 overtime as required (occasional weekend work)

Preferred
• Experience in cell culture and/or protein purification
• Technical understanding of a biotech manufacturing facility
• Experience with single-use technologies
• Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders
• 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

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 39.00/hr.