Location: San Diego, CA
- Focus on development work to develop scalable and robust processes on accelerated timelines.
- Independently writes study protocols, experimental designs, tech transfer reports, and development reports.
- Conduct activities in support of production schedules and objectives as directed by senior staff.
- Maintains records to comply with regulatory requirements and assist with in-process testing.
- Perform manufacturing and process development activities for projects and products in collaboration with others.
- Completes laboratory work and associated paperwork by assigned completion dates.
- Provides training to new personnel in a specific technical process.
- Represents departmental activities as needed, including project teams, training, and evaluation of new technologies.
- Prepares components, media, buffers, and other solutions as needed.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.
- Travels as needed to attend professional conferences, train on new technologies, and execute process transfer in support of clients.
- AA/AS or BA/BS degree that included laboratory work in a chemistry, biology, chemical engineering or related field.
- Minimum of three (3) years of experience as a Manufacturing Associate, or equivalent, in a GMP environment
- Ability to work independently or as a team member.
- Ability to follow instructions with minimal supervision, and to maintain accurate records and notes.
- Ability to organize workload, oversee workload of associates and lab technicians, and relevant resource requirements.
- Skill in leadership duties, to include time management and planning.
- Skill with chromatography, ultrafiltration, normal flow filtration, and single-use technologies or cell culture parameters (for various cell lines) and nutrient requirement in shaker flasks and disposable bioreactors up to 25L for production .
- Ability to follow detailed instructions and to maintain accurate records and notes.
- Ability to work effectively in a team environment.
- Ability to successfully perform multiple tasks and changing priorities, when required.
- Skills in problem solving and troubleshooting .
- Ability to safely operate production equipment in accordance with established practices.