Position Title: Associate I, Technical Development Operations
Work Location: South San Francisco, CA 94080
Assignment Duration: 6 Months
Work Arrangement: Onsite

Position Summary: This position reports to the Lead, Technical Department Operations in the Technical Development Department within the Cell and Gene Therapy Research Division.

Background & Context: 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. This is a lab and office-centric position that requires onsite work.

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.

Qualification & Experience:
• 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).
• 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: $ 37.00/hr.