Supervisor, CGMP Manufacturing; Upstream​/Downstream

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The Supervisor, CGMP Manufacturing – Downstream leads day-to-day downstream peptide production at our cGMP facility, including preparative HPLC purification, lyophilization, and final packaging, delivering purified peptide API safely, on schedule, and in compliance with cGMP.

This is a hands-on role reporting to the Operations Manager, with direct authority over downstream production staff, scheduling, and floor execution. You will work closely with your upstream counterpart to hand off material smoothly and keep campaigns on schedule.

This role is based in Menlo Park, CA at our H&H Peptides facility.

• Direct cGMP SPPS operations, including resin preparation, coupling and deprotection cycles, in-process checks, and resin washing and drying.
• Direct cleavage operations, including cocktail preparation, cleavage, filtration, precipitation, and isolation of crude peptide.
• Ensure upstream execution follows approved batch records, SOPs, and safety requirements, including safe handling of hazardous solvents and reagents (e.g., DMF, piperidine, TFA).

• Direct cGMP purification operations, including prep HPLC column packing and equilibration, loading, gradient runs, fraction collection, and pooling.
• Direct lyophilization and final isolation operations, including cycle execution, unloading, and final packaging and labeling.
• Ensure downstream execution follows approved batch records, SOPs, and safety requirements, and coordinate with QC on in-process and release testing.

• Oversee equipment readiness across upstream and downstream, including synthesizers, cleavage vessels, prep HPLC systems, lyophilizers, and packaging equipment, in coordination with Engineering and Maintenance.
• Oversee equipment qualification, preventive maintenance, and vendor relationships.
• Troubleshoot issues on the floor in real time and elevate appropriately.

• Build and manage the integrated upstream and downstream production schedule, balancing synthesizer, vessel, column, and lyophilizer capacity, staffing, material availability, and QC turnaround.
• Plan campaigns across multiple concurrent products, and own schedule attainment and on-time delivery.
• Coordinate the hand-off of crude peptide from upstream to downstream, and work with Supply Chain and Quality to keep batches moving.

• Lead investigations of deviations, failed batches, and process excursions; conduct root cause analysis and implement corrective and preventive actions.
• Author, review, and maintain master batch records, SOPs, and work instructions in partnership with Quality and Process Development.
• Support scale-up, tech transfer, and new product introductions, including process validation and PPQ campaigns, in partnership with Process Development.
• Drive yield, throughput, and cost-efficiency improvements, using process data and…