Associate I, Technical Development Operations

Job Description

Job Summary:

• This position reports to the Lead, Technical Department Operations in the Technical Development Department within the Client 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.

Duties and 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.

Required Qualifications:

• 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 Qualifications:

• 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.