Associate I, Technical Development Operations (Downstream Purification)

Zenith LifeScience LLC.; South San Francisco (CA); On-site; USD 55,000 - 85,000; Full time

Job summary

Zenith LifeScience LLC. in South San Francisco, CA, seeks an Associate I to participate in downstream areas of AAV development and production within process development for gene therapy programs and processes.

You will perform operations, support downstream purification unit operations, operate production equipment, document activities, and contribute to process improvements in a lab and office-based setting onsite.

Qualifications

• BS in Life Science or Engineering or equivalent experience.
• 0-2+ years in a pharmaceutical/biologics lab or manufacturing environment.
• Understanding of downstream process theory and equipment operation.
• Strong communication and teamwork abilities.
• Detail-oriented with record-keeping and documentation skills.
• Willingness to work outside normal business hours or overtime as required.

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, setup, 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, including maintaining a safe work environment.
• Ability to contribute to process improvement plans and drive to completion.
• Conduct operations in a collaborative, team environment with a positive attitude.
• 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.
• onsite work required (lab and office-centric position).

Skills

Effective communication

Record keeping

Problem solving

Independent work

Team collaboration

Education

BS in Life Science or Engineering

Tools

TFF systems

Chromatography

Sterile filtration

Job description

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.

• 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
• 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