Supervisor, CGMP Manufacturing (Upstream / Downstream)

Hims & Hers • Menlo Park, CA

6d • $100,000 - $120,000 • Onsite

About The Position

The Supervisor, CGMP Manufacturing – Downstream leads day-to-day peptide production at Hims & Hers’ cGMP facility. The role oversees upstream and downstream operations, including solid-phase peptide synthesis (SPPS), cleavage, preparative HPLC purification, lyophilization, final isolation, and packaging, ensuring purified peptide API is produced safely, on schedule, and in compliance with cGMP requirements.

This is a hands-on supervisory role with direct authority over production staff, scheduling, and floor execution. The supervisor builds and manages integrated production schedules, coordinates upstream-to-downstream handoffs, oversees equipment readiness and maintenance, and collaborates with Quality, QC, Engineering, Maintenance, Supply Chain, and Process Development.

The role also leads investigations and corrective actions, maintains manufacturing documents and systems, supports scale-up, technology transfer, validation and PPQ campaigns, and drives yield, throughput, and cost-efficiency improvements. The supervisor maintains inspection readiness and regulatory compliance, develops and trains the team, and fosters a culture of safety, accountability, initiative, and open communication. The position is based at the H&H Peptides facility in Menlo Park, California, and reports to the Operations Manager.

Requirements

• Bachelor’s degree in chemistry, biochemistry, chemical engineering, or a related discipline.
• At least 3 years of cGMP manufacturing experience in pharmaceutical, biopharmaceutical, or peptide manufacturing.
• Hands-on experience with preparative HPLC purification and lyophilization.
• At least 1 year in a leadership or supervisory role managing production teams.
• Strong working knowledge of cGMP batch execution, deviations, CAPAs, and data integrity.
• Strong problem-solving, communication, and organizational skills in a small, fast-moving environment.

Nice To Haves

• Experience with commercial-scale SPPS (upstream) or prep HPLC and lyophilization (downstream).
• Experience supporting process validation, PPQ campaigns, and technology transfer of new peptide products into GMP manufacturing.
• Experience with budget oversight, capital projects, vendor management, and staffing.
• Experience with MES/electronic batch record systems and continuous improvement initiatives.

Responsibilities

• 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 crude peptide isolation.
• Ensure upstream execution follows approved batch records, SOPs, and safety requirements, including safe handling of hazardous solvents and reagents such as DMF, piperidine, and TFA.
• Direct cGMP purification operations, including preparative HPLC column packing and equilibration, loading, gradient runs, fraction collection, and pooling.
• Direct lyophilization and final isolation operations, including cycle execution, unloading, 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 readiness of 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 floor issues in real time and escalate appropriately.
• Build and manage the integrated upstream and downstream production schedule, balancing equipment capacity, staffing, material availability, and QC turnaround.
• Plan campaigns across multiple concurrent products and own schedule attainment and on-time delivery.
• Coordinate crude peptide handoffs 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, new product introductions, process validation, and PPQ campaigns in partnership with Process Development.
• Drive yield, throughput, and cost-efficiency improvements using process data and historical performance to set targets.
• Support the design, implementation, and continuous improvement of manufacturing systems, including electronic batch records.
• Keep the area inspection-ready and ensure batch records, logbooks, and equipment records are complete, accurate, and compliant with ALCOA+ and 21 CFR Part 11.
• Ensure manufacturing operations comply with cGMP, internal SOPs, and master batch records under 21 CFR 210/211 and ICH Q7.
• Support audits and regulatory inspections by preparing the area, hosting walkthroughs, and owning responses, CAPAs, and follow-up commitments through on-time completion.
• Provide manufacturing data and documentation to support regulatory submissions and data integrity.
• Lead, coach, and develop chemists, operators, and technicians across upstream and downstream; set expectations and performance metrics and conduct regular performance reviews.
• Own onboarding and GMP training, maintain training matrices and qualifications, and build cross-training and shift coverage.
• Lead hands-on, understand operations at the task level, observe workflows for bottlenecks, and help solve problems on the floor as needed.
• Foster a culture of safety, initiative, accountability, and open communication.

Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits, including medical, dental, and vision coverage, and parental leave.
• Employee Stock Purchase Program (ESPP).
• 401(k) benefits with employer matching contribution.
• Offsite team retreats.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager