* Leads manufacturing associates and lab technicians in execution of production activities.
* Responsible for specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to Scientific/Manufacturing senior staff.
* Duties involving aseptic technique, bioreactor operation and single-use technologies.
* Operates and maintains production equipment with single-use materials as it relates to cell culture (Wave bioreactors, incubators, shakers, and cell separation equipment).
* Conducts activities in support of production schedules and objectives as directed by Scientists.
* Obtains and stock supplies as needed.
* Prepares media and stock solutions.
* Maintains records to comply with regulatory requirements and assist with in-process testing.
* Provides detailed observations, analyzes data, and interprets results.
* Prepares technical reports, summaries, protocols, batch records and quantitative analyses.
* Provides solutions to difficult, though defined problems associated with specific projects.
* Assists downstream in buffer prep and harvest operations.
* Perform manufacturing and process development activities for projects and products in collaboration with others.
* Provides training to new personnel in a specific technical process.
* Provide input and feedback on performance of production associates and lab technicians.
* Participate in process improvement activities.
* Represents departmental activities as needed, including project teams, training, and evaluation of new technologies.
* 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 biology, microbiology, chemical engineering or related field.
* Minimum three (3) years of experience as an Upstream/Production Associate, or equivalent, in a GMP environment.
* Knowledge of mammalian cell culture for production of biopharmaceuticals.
* Skill with aseptic technique, bioreactor operation and single-use technologies.
* 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.
* Ability to work effectively in a team environment.
* Ability to successfully perform multiple tasks, when required.
* Skills in problem solving and troubleshooting.
* Ability to safely operate production equipment in accordance with established practices.