Director, Technical Services

About the Role:

Hims & Hers is scaling a multi-site sterile and nonsterile manufacturing network spanning 503A compounding pharmacies, a 503B outsourcing facility, and a new peptide active pharmaceutical ingredient (API) manufacturing site. The Director, Technical Services is a newly created, cross-site leadership role responsible for technology transfer, cleaning validation, process validation, and hands-on process and equipment troubleshooting across all sites. This role partners closely with site Operations, Quality, R&D, and Engineering leaders to keep manufacturing processes running reliably and to resolve technical issues quickly as the network grows. This position will define and own the multi-site Technical Services strategy that supports the product lifecycle in our operations.

This role also provides technical leadership and people management for the site-level Technical Services Managers across the network, setting consistent standards for process validation, cleaning validation, and technology transfer execution at each site.

You Will:

Technology Transfer

• Lead technology transfer of new products, formulations, and processes into and between the company's sterile and nonsterile compounding, 503B, and peptide API manufacturing sites, including transfers from internal R&D resources.
• Own transfer protocols and reports, ensuring critical process parameters, in-process controls, and acceptance criteria are clearly defined and successfully demonstrated at the receiving site.
• Coordinate cross-functionally with R&D, Quality, and Operations to ensure a smooth, well-documented transition from development or donor site to routine commercial production.

Cleaning Validation

• Own the cleaning validation program across sites, including cleaning method development, worst-case product/equipment grouping, swab and rinse sampling strategy, and acceptance limit calculations.
• Author and execute cleaning validation protocols and reports for compounding, filling, and API processing equipment, and manage the ongoing cleaning verification/monitoring program.
• Assess cleaning validation impact of new products, equipment, or campaign changes, and determine when revalidation is required.

Process Validation

• Lead process validation activities for sterile and nonsterile compounded preparations at the 503A sites, and for sterile manufacturing at the 503B site, including aseptic process simulations where applicable.
• Lead process validation for peptide API manufacturing, covering process design through process qualification and continued process verification.
• Author and execute process validation protocols and reports, define sampling plans and acceptance criteria, and ensure validation outcomes are clearly documented and defensible.
• Own the network-wide process validation program that site Technical Services Managers execute as ongoing process verification at each site, ensuring site-level verification activities remain aligned to the validated state and escalated deviations are resolved consistently across sites.

Process Troubleshooting & Improvement

• Serve as the go-to technical resource for diagnosing and resolving process deviations, yield losses, and quality issues across all four sites.
• Lead root-cause investigations for process-related deviations and drive corrective and preventive actions.
• Identify and lead continuous improvement projects to increase process robustness, throughput, and consistency across sterile, nonsterile, and API manufacturing operations.

Equipment Troubleshooting

• Provide hands-on technical troubleshooting support for compounding, filling, sterilization, and API processing equipment when performance issues, breakdowns, or unexpected results occur.
• Partner with site Engineering and Maintenance teams to diagnose equipment-related root causes and implement fixes that restore or improve equipment reliability.
• Support commissioning and start-up troubleshooting for new or upgraded equipment during site qualification and launch phases at newly onboarded or expanding sites.

Site Program Oversight

• Set network-level strategy and standards for process development scale-up support, capital equipment installation, and Equipment IOQ/PQ execution performed by site Technical Services Managers.
• Review and approve site-level IOQ/PQ and requalification protocols for consistency, risk-based rigor, and inspection readiness across the network.
• Track site requalification schedules and change-control triggers across the network, ensuring site teams remain current and escalating resourcing gaps as needed.

Team Leadership

• Manage, coach, and develop the site Technical Services Managers across the network, setting clear technical priorities and holding each site accountable for quality, timeliness, and consistency of validation and troubleshooting work.
• Own hiring, onboarding, and career development planning for site Technical Services Managers, in partnership with site leadership and HR.
• Establish and maintain network-wide technical standards, training, and knowledge-sharing forums to build Technical Services capability and consistency across sites.

Regulatory Inspection Participation

• Participate in FDA and state board of pharmacy inspections as a technical subject matter expert, providing front-room or back-room support as needed.
• Respond to inspector questions and provide documentation related to technology transfer, cleaning validation, process validation, and process/equipment troubleshooting history for the site under inspection.
• Assist in preparing inspection-ready technical documentation and data packages, and support drafting of technical responses to observations tied to process, cleaning, or equipment performance.

You Have:

• Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related technical/scientific field required; advanced degree preferred.
• 12+ years of progressive experience in pharmaceutical manufacturing or sterile/nonsterile compounding, with direct, hands-on ownership of technology transfer, cleaning and process validation, or process/equipment troubleshooting.
• Demonstrated expertise across at least two of the following: 503A/503B compounding operations, sterile injectable manufacturing, and API/peptide manufacturing or process chemistry.
• Working knowledge of USP <795>, <797>, and <800>; FDA's Process Validation Guidance (2011); and ICH Q7/Q11 for API manufacturing.
• Strong root-cause investigation and CAPA experience, with a track record of resolving process and equipment issues in a regulated manufacturing environment.
• Proven ability to work across geographically distributed sites, including remote team collaboration and site travel.
• Strong technical writing skills and comfort producing and reviewing technology transfer, cleaning validation, and process validation protocols and reports.
• Prior experience managing or developing managers/supervisors in a multi-site or matrixed manufacturing organization.

Preferred:

• Experience with peptide, oligonucleotide, or other complex API manufacturing and associated technology transfers.
• Hands-on equipment troubleshooting experience with autoclaves, isolators, filling lines, or API processing/purification equipment.
• Experience supporting new equipment commissioning or site launch activities.
• Prior experience participating in FDA inspections, including front-room or back-room technical support roles.