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Company

Original Job Post

Metagenomi · 3 days ago

Senior Manufacturing Associate

Emeryville, California, United States

Contract

Onsite

Senior Level

$46/hr - $63/hr

5+ years exp

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Responsibilities

Perform daily gene therapy production processes, including vector production, purification, and formulation.

Follow established protocols and standard operating procedures (SOPs) to ensure consistent and high-quality product output.

Conduct in-process testing and sampling to monitor production quality and process parameters.

Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP) and relevant regulatory requirements.

Actively engage with quality systems (deviations, CAPA, change controls, root cause analysis).

Maintain accurate and thorough documentation of production activities and project progress.

Participate in internal and external audits, providing necessary documentation and support.

Operate, maintain, and troubleshoot manufacturing equipment and systems, ensuring optimal performance and minimal downtime.

Coordinate with maintenance teams to schedule and perform routine equipment calibrations and preventive maintenance.

Identify opportunities for process improvements and implement strategies to enhance production efficiency and product quality.

Collaborate with cross-functional teams to develop and refine manufacturing processes and protocols.

Utilize data-driven approaches to analyze production metrics and drive continuous improvement initiatives.

Support and actively contribute to initiatives to foster a Continuous Improvement culture.

Work closely with other departments to support production goals and timelines.

Communicate effectively with team members and supervisors regarding production status, challenges, and opportunities for improvement.

Prepare and present project updates and reports to management and stakeholders.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Gene therapyBiopharmaceutical manufacturingAseptic techniquesGMPFDA regulationsRegulatory requirementsProduction equipmentBioreactorsChromatography systemsFiltration unitsData-driven decision makingProblem-solvingAnalyticalCommunicationInterpersonalCollaboration

Required

Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Biotechnology

A minimum of five years of experience in gene therapy or biopharmaceutical manufacturing

Proficiency in aseptic techniques and closed system processing. Strong understanding of GMP, FDA, and other regulatory requirements related to gene therapy manufacturing

Experience with production equipment, including bioreactors, chromatography systems, and filtration units

Strong analytical and problem-solving abilities, with a focus on troubleshooting and optimizing production processes

Ability to make data-driven decisions and implement effective solutions in a fast-paced environment

Excellent verbal and written communication skills, with the ability to interact effectively with team members and other departments

Strong interpersonal skills and the ability to collaborate effectively in a team-oriented environment