Director, Technical Services

Openkrill; United States; Remote; USD 150,000 - 190,000; Full time

Job summary

Hims & Hers is expanding its multi-site sterile and nonsterile manufacturing network, spanning compounding pharmacies, an outsourcing facility, and a peptide API site. The Director, Technical Services will own technology transfer, cleaning validation, and process validation across all locations and partner with Operations, Quality, R&D, and Engineering to ensure reliable manufacturing.

The role requires at least 12+ years in pharma manufacturing, leadership of validation programs, and strong

Qualifications

• Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field.
• 12+ years of progressive pharmaceutical manufacturing or sterile/nonsterile experience.
• Experience leading tech transfer, cleaning validation, process validation, or troubleshooting.

Responsibilities

• Lead technology transfer across sterile/nonsterile, 503A/503B, and peptide API sites.
• Own cleaning and process validation programs; define sampling plans and acceptance criteria.
• Lead root-cause investigations and drive CAPA for deviations and quality issues.

Skills

Root-cause investigation

CAPA

Cross-site collaboration

Technical writing

Project management

Travel readiness

Education

Bachelor's degree

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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals.

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.

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 deve