Associate I, Technical Development Operations

Job Description:

Purpose & Scope:

This position reports to the Lead, Technical Department Operations in the Technical Development Department within the company’s Cell and Gene Therapy Research Division. 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 position will be located in South San Francisco, CA.

Essential Job 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
• This is a lab and office-centric position that requires onsite work.

Qualifications:

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