Associate I, Technical Development Operations

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.