Associate Director, Downstream Manufacturing
Company: ZYLIDAC BIO LLC
Location: Emeryville
Posted on: February 17, 2026
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Job Description:
Job Description Job Description Description: Collaborate with
the upstream manufacturing managers as it relates to the production
activities andguidance of the manufacturing group. Responsible for
manufacturing related to product development, clinical and
commercial production. Ensuring and utilizing resources (personnel,
equipment, facilities, supplies, etc.) to meet production demands.
Direct all aspects of chemical weighing preparation for GMP and
non-GMP activities. Direct all aspects of buffer solution
preparation for GMP and non-GMP activities. Direct all aspects of
downstream operations for GMP and non-GMP activities. Direct all
aspects of filling and visual inspection operations for GMP and
non-GMP activities. Ensure adequate supplies of GMP raw materials
and consumables are available based on the projects. Responsible
for process evaluation, improvement and implementation, data
collection and management, creation, utilization and review of
documentation, conformance to Standard Operation Procedures (SOP)
and compliance to Good Manufacturing Practices (GMP). Lead and
direct projects/programs for the manufacturing Downstream,
Filling/Visual Inspection, and Label/Packaging groups. Provide
training, guidance, and mentoring to junior staff and coordinate
the assistance of other operations staff. Point person for resource
planning for manufacturing. Subject matter expert for GMP, large
scale manufacturing operations. Hiring, training and the
development of staff. Assist Director of GMP Manufacturing with
strategic planning and guidance of the manufacturing group.
Requirements: Experience in (any or all) technology transfer,
validation, filling, and/or facility start-up. Thorough knowledge
of bioprocess validation and associated documentation. Effective
communication skills. BS degree in life or physical sciences.
Minimum 10 years of GMP biopharmaceutical manufacturing. Previous
management and leadership experience.
Keywords: ZYLIDAC BIO LLC, Fairfield , Associate Director, Downstream Manufacturing, Manufacturing , Emeryville, California
