Lead Upstream Production Associate - Manufacturing


San Diego, CA

Industry: Manufacturing


Less than 5 years

Posted 157 days ago

  by    Maritza Razo

This job is no longer available.

Position Responsibilities:

*        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.

 General Responsibilities:

*        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.

Qualifications/Skills Required:

*        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.

FLSA: Exempt