Associate I, Technical Development Operations Location: South San Francisco, CA (onsite) Duration: 6-month assignment
Purpose & Scope :
This position reports to the Lead, Technical Department Operations in the Technical Development Department within the Company Cell and Gene Therapy Research Division. The associate will participate in downstream areas of AAV development and production within process development 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 downstream process development activities
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 downstream process theory (i.e., Depth Filtration, 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 biologics (protein, enzyme, AAV) 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
Numbers & Facts
Location
South San Francisco, CA
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Chromatographyunmatched
Column Chromatographyunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Equipment Specificationunmatched
GMP (Good Manufacturing Practices)unmatched
Gene Therapyunmatched
Laboratory Techniquesunmatched
Manufacturingunmatched
Manufacturing Methodsunmatched
Microsoft Excelunmatched
Microsoft Officeunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Multitaskingunmatched
Operational Improvementunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Process Improvementunmatched
Record Keepingunmatched
Safety Processunmatched
Safety/Work Safetyunmatched
Team Playerunmatched
Technical Operationsunmatched
Time Managementunmatched
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