Supervisor, CGMP Manufacturing (Upstream / Downstream)

Hims & Hers; Menlo Park (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary and equity

Unlimited PTO

Comprehensive health benefits

ESPP

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers seeks a Supervisor, CGMP Manufacturing – Downstream, to lead day-to-day peptide production at our cGMP facility in Menlo Park, CA. The role involves direct oversight of downstream purification, lyophilization, and packaging, with close collaboration with upstream and QC teams to ensure on-time delivery.

You will manage schedules, drive continuous improvement, and develop front-line staff while ensuring compliance with 21 CFR Part 11 and ALCOA+ data integrity standards.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, chemical engineering, or related discipline.
• 3+ years of cGMP manufacturing experience in pharmaceutical/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.

Responsibilities

• Direct cGMP SPPS operations and downstream purification processes per batch records and SOPs.
• Oversee downstream purification, lyophilization, and final packaging operations, coordinating with QC for testing.
• Manage equipment readiness across upstream and downstream (SPS, prep HPLC, lyophilizers, packaging).
• Build and manage integrated upstream/downstream production schedule and campaigns across products.
• Lead investigations of deviations, deviations, and process excursions; implement CAPAs and maintain master batch records.
• Lead GMP training, onboarding, and development of chemists, operators, and technicians.

Skills

cGMP manufacturing

HPLC purification

Lyophilization

Leadership

Data integrity

Education

Bachelor’s degree in chemistry/biochemistry/chemical engineering

Tools

HPLC systems

Lyophilizers

MES/eBRS

Job description

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.

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, 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.

You Will:

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, including safe handling of hazardous solvents and reagents (e.g., DMF, piperidine, TFA).

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, and coordinate with QC on in-process and release testing.

Equipment & Floor Operations:

• 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.

Scheduling:

• 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.

Process, Quality & Continuous Improvement:

• 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.

Audit Readiness & Compliance:

• 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.

Team Development:

• 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.

You Have:

• 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.

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.

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• 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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.