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Hims & Hers, a leading health and wellness platform and NYSE-traded public company, is seeking a Supervisor for CGMP Manufacturing to lead day-to-day operations at their H&H Peptides facility in Menlo Park, CA. This hands-on supervisory role oversees both upstream and downstream peptide production, reporting to the Operations Manager with direct authority over production staff, scheduling, and floor execution.
UPSTREAM RESPONSIBILITIES:
You will direct cGMP solid-phase peptide synthesis (SPPS) operations, including resin preparation, coupling and deprotection cycles, in-process checks, and resin washing/drying. You'll manage cleavage operations—cocktail preparation, cleavage, filtration, precipitation, and crude peptide isolation—ensuring all work follows approved batch records, SOPs, and safety protocols for hazardous solvents (DMF, piperidine, TFA).
DOWNSTREAM RESPONSIBILITIES:
You will direct cGMP purification operations using preparative HPLC, including column packing, equilibration, loading, gradient runs, fraction collection, and pooling. You'll oversee lyophilization and final isolation, including cycle execution, unloading, packaging, and labeling. You'll coordinate with QC on in-process and release testing and ensure all work complies with batch records and SOPs.
EQUIPMENT & OPERATIONS:
Oversee equipment readiness across synthesizers, cleavage vessels, prep HPLC systems, lyophilizers, and packaging equipment in coordination with Engineering and Maintenance. Manage equipment qualification, preventive maintenance, and vendor relationships. Troubleshoot floor issues in real time and escalate appropriately.
SCHEDULING & PLANNING:
Build and manage integrated upstream/downstream production schedules, balancing synthesizer, vessel, column, and lyophilizer capacity against staffing, material availability, and QC turnaround. Plan concurrent multi-product campaigns, own schedule attainment and on-time delivery, and coordinate crude peptide hand-offs from upstream to downstream with Supply Chain and Quality.
QUALITY & CONTINUOUS IMPROVEMENT:
Lead investigations of deviations, failed batches, and process excursions; conduct root cause analysis and implement corrective/preventive actions. Author, review, and maintain master batch records, SOPs, and work instructions with Quality and Process Development. Support scale-up, tech transfer, and new product introductions including process validation and PPQ campaigns. Drive yield, throughput, and cost-efficiency improvements using process data and historical performance. Support design and continuous improvement of manufacturing systems including electronic batch records.
AUDIT READINESS & COMPLIANCE:
Maintain inspection-ready operations; 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 area preparation, walkthroughs, and owning responses, CAPAs, and follow-up commitments. Provide manufacturing data and documentation for regulatory submissions with data integrity assurance.
TEAM DEVELOPMENT:
Lead, coach, and develop chemists, operators, and technicians across upstream and downstream. Set clear expectations and performance metrics; conduct regular performance reviews. Own onboarding and GMP training; maintain training matrices and qualifications; build cross-training and shift coverage. Lead hands-on by understanding operations at the task level, observing workflows to identify bottlenecks, and solving problems directly on the floor. Foster a culture of safety, initiative, accountability, and open communication.
REQUIREMENTS:
- Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or 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
PREFERRED QUALIFICATIONS:
- 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
