Supervisor, CGMP Manufacturing (Upstream / Downstream)

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

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 escalate 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 historical performance to set targets.

• Support the design, implementation, and continuous improvement of manufacturing systems, including electronic batch records, keeping them compliant, practical, and easy for front-line teams to use.

• Keep the area inspection-ready at all times; 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 per 21 CFR 210/211 and ICH Q7.

• Support audits and regulatory inspections, including 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, ensuring data integrity.

• Lead, coach, and develop chemists, operators, and technicians across upstream and downstream; set clear 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 to find bottlenecks, and help solve problems directly on the floor when needed.

• Foster a culture of safety, initiative, accountability, and open communication where issues are raised early and resolved promptly.

• Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, or a related discipline.

• 3+ years of cGMP manufacturing experience in pharmaceutical, biopharmaceutical, or peptide manufacturing

• Hands-on experience with preparative HPLC purification and lyophilization

• 1+ years 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.

• Experience with commercial-scale SPPS (upstream) or prep HPLC and lyophilization (downstream).

• Experience supporting process validation, PPQ campaigns, and tech 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.