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Supervisor, CGMP Manufacturing (Upstream / Downstream)

Hims & Hers· OPERATIONS
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Menlo Park, California$100k - $120kFull-timePosted 5d ago

About the role

Lead day-to-day downstream peptide production at a cGMP facility, coordinating upstream/downstream activities, ensuring compliance with cGMP, and delivering purified peptide API on schedule.

Responsibilities

  • Upstream Execution: Direct cGMP SPPS operations, including resin preparation, coupling and deprotection cycles, in-process checks, and resin washing and drying.
  • Downstream Execution: Direct cGMP purification operations, including prep HPLC column packing and equilibration, loading, gradient runs, fraction collection, and pooling.
  • Lyophilization and final isolation: Direct lyophilization and final isolation operations, including cycle execution, unloading, and final packaging and labeling.
  • Quality & Compliance: Ensure batch records, SOPs, and safety requirements are followed; coordinate with QC on in-process and release testing.
  • Equipment & Floor Operations: Oversee readiness and maintenance of synthesis, purification, and packaging equipment; manage qualification and vendor relationships.
  • Scheduling: Build and manage integrated upstream/downstream production schedule; plan campaigns and ensure on-time delivery.
  • Process, Quality & Continuous Improvement: Lead investigations, develop CAPAs, author master batch records and SOPs, support tech transfer and process validation.
  • Audit Readiness & Compliance: Maintain inspection-ready areas, support audits, and provide data for regulatory submissions.
  • Team Development: Lead and develop chemists, operators, and technicians; oversee onboarding and GMP training; promote safety and accountability.

Qualifications

  • 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 fast-paced environment.

Skills

Required:cGMP manufacturingHPLC purificationLyophilizationLeadership / Team Management

Benefits

  • 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
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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