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New Albany, Ohio, United States
Onsite
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.
Hims & Hers is scaling a multi-site sterile and nonsterile manufacturing network spanning 503A compounding pharmacies, a 503B outsourcing facility, and a peptide active pharmaceutical ingredient (API) manufacturing site. The Manager, Technical Services is the site-level technical owner responsible for executing process verification, cleaning validation, and technology transfer activities, driving process optimization, and resolving equipment and process issues at their assigned facility. This role reports to the Director, Technical Services and works closely with site Operations, Quality, Engineering, and Maintenance to keep manufacturing running reliably day to day, while supporting process development, capital equipment installation, equipment qualification, and requalification work as the site grows.
Process Verification
Execute process verification activities for compounded preparations and manufacturing processes at the site, confirming that critical process parameters and in-process controls are consistently met.
Author and execute process verification protocols and reports, and maintain supporting data packages for audit and inspection readiness.
Flag process drift or emerging trends to site leadership and the Director, Technical Services, and recommend corrective action.
At sterile sites, plan and execute site-level aseptic process simulations (media fills) in line with network standards set by the Director, Technical Services, and support any related investigations.
Cleaning Validation
Execute the site's cleaning validation program, including cleaning method verification, swab and rinse sampling, and acceptance limit checks for compounding, filling, and processing equipment.
Author and execute cleaning validation protocols and reports, and manage the ongoing cleaning verification/monitoring schedule for the site.
Assess the cleaning validation impact of new products, equipment changes, or campaign changes at the site, and escalate revalidation needs to the Director, Technical Services.
Tech Transfer
Support and execute technology transfer of new products, formulations, and processes into the site, including transfers from R&D or from other manufacturing sites.
Coordinate site-level activities against transfer protocols, ensuring critical process parameters and acceptance criteria are met during transfer runs.
Partner with R&D, Quality, and Operations to document a smooth, well-supported transition from transfer to routine commercial production at the site.
Process Optimization
Identify and lead site-level continuous improvement projects to increase process robustness, throughput, and consistency.
Analyze process and yield data to identify optimization opportunities, and implement changes through the site's change control process.
Partner with Operations to translate optimization initiatives into standard work and operator training updates.
Equipment Troubleshooting
Serve as the site's first-line technical resource for diagnosing and resolving equipment performance issues, breakdowns, or unexpected results on compounding, filling, sterilization, or API processing equipment.
Partner with site Engineering and Maintenance to identify equipment-related root causes and implement fixes that restore or improve reliability.
Support commissioning and start-up troubleshooting for new or upgraded equipment during site qualification and launch phases.
Process Investigations
Lead or support root-cause investigations for process-related deviations, yield losses, and quality issues at the site.
Drive corrective and preventive actions (CAPA) to closure, and verify effectiveness of implemented changes.
Maintain clear, defensible investigation documentation suitable for internal review and regulatory inspection.
Regulatory Inspection Support
Participate in FDA and state board of pharmacy inspections as the site's technical subject matter expert, providing front-room or back-room support as needed.
Respond to inspector questions and provide documentation on process verification, cleaning validation, technology transfer, and troubleshooting history for the site, and support technical responses to observations tied to process, cleaning, or equipment performance.
Team Leadership
Lead, coach, and develop the site's Technical Services team, setting clear priorities and holding the team accountable for quality, timeliness, and safety of their work.
Own hiring, onboarding, performance management, and career development for direct reports, in partnership with HR.
Plan team workload and capacity across process verification, cleaning validation, tech transfer, and troubleshooting activities to meet site production and compliance timelines.
Build technical capability on the team through training, mentorship, and knowledge-sharing on validation practices and equipment troubleshooting.
In addition to the primary responsibilities above, this role provides site-level support for the following:
Process Development — supporting scale-up and process definition activities for new products transitioning from R&D to the site.
Capital Install — supporting installation and startup activities for new capital equipment, including coordination with Engineering and vendors.
Equipment IOQ/PQ — supporting Installation, Operational, and Performance Qualification execution for new or upgraded equipment.
Requalification — supporting periodic requalification of equipment and processes per site schedules and change control triggers.
Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related technical/scientific field required.
5+ years of experience in pharmaceutical manufacturing or sterile/nonsterile compounding, with hands-on experience in process verification, cleaning validation, technology transfer, or equipment troubleshooting.
Prior experience supervising or leading technical staff, including hiring, coaching, and performance management, in a regulated manufacturing or compounding environment.
Working knowledge of USP <795>, <797>, and <800> (as applicable to site), FDA's Process Validation Guidance (2011), and cGMP requirements.
Experience supporting root-cause investigations and CAPA in a regulated manufacturing environment.
Strong technical writing skills, with the ability to author clear, defensible protocols and reports.
Comfort working hands-on with manufacturing equipment and collaborating cross-functionally with Operations, Quality, and Engineering.
Experience with peptide, oligonucleotide, or other complex API manufacturing processes.
Hands-on experience with autoclaves, isolators, filling lines, or API processing/purification equipment.
Experience supporting new equipment commissioning, IOQ/PQ execution, or site launch activities.
Prior experience supporting FDA or state board of pharmacy inspections.
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. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
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.
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 & 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 accommodations@forhims.com 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. Please do not send resumes to this email address.
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