# Supervisor, CGMP Manufacturing (Upstream / Downstream)

**Company**: Hims & Hers
**Location**: Menlo Park, California
**Work arrangement**: onsite
**Experience**: senior
**Job type**: Full time
**Salary**: $100K – $120K
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://jobs.ashbyhq.com/hims-and-hers/4b2c297a-d111-46cb-9fc0-7f083d86d144?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e2563662-265

## Description

## Compensation

The salary range for this role is $100K – $120K, with equity offered.

## About the Role:

The Supervisor, CGMP Manufacturing – Downstream leads day-to-day downstream peptide production at our cGMP facility, including preparative HPLC purification, lyophilization, and final packaging.

## Responsibilities:

### Upstream Execution:

- 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.

### Downstream Execution:

- 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.

### Equipment & Floor Operations:

- Oversee equipment readiness across upstream and downstream.

- Oversee equipment qualification, preventive maintenance, and vendor relationships.

- Troubleshoot issues on the floor in real time and escalate appropriately.

### Scheduling:

- Build and manage the integrated upstream and downstream production schedule.

- Plan campaigns across multiple concurrent products.

- Coordinate the hand-off of crude peptide from upstream to downstream.

### Process, Quality & Continuous Improvement:

- Lead investigations of deviations, failed batches, and process excursions.

- Author, review, and maintain master batch records, SOPs, and work instructions.

- Support scale-up, tech transfer, and new product introductions.

- Drive yield, throughput, and cost-efficiency improvements.

### Audit Readiness & Compliance:

- Keep the area inspection-ready at all times.

- Ensure manufacturing operations comply with cGMP, internal SOPs, and master batch records.

- Support audits and regulatory inspections.

### Team Development:

- Lead, coach, and develop chemists, operators, and technicians.

- Own onboarding and GMP training.

- Foster a culture of safety, initiative, accountability, and open communication.

## Requirements:

- 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.

## 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.

## Benefits:

- Competitive salary & equity compensation.

- Unlimited PTO, company holidays, and quarterly mental health days.

- Comprehensive health benefits including medical, dental & vision, and parental leave.

- Employee Stock Purchase Program (ESPP).

- 401k benefits with employer matching contribution.

- Offsite team retreats.

## Skills

### Required
- cGMP
- SPPS
- HPLC
- lyophilization
- leadership
- quality control

### Nice to have
- commercial-scale SPPS
- process validation
- PPQ campaigns
- tech transfer

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Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/4b2c297a-d111-46cb-9fc0-7f083d86d144?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)