Director, Technical Services

5 дн. назад

195k–215k USD / yearUSADirectorRemote

process validationtechnology transferequipment troubleshooting

Leadership role responsible for technology transfer, cleaning validation, process validation, and equipment troubleshooting across multiple manufacturing sites in health and wellness.

Обязанности

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.

Требования

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.

Будет плюсом

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.

Условия

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

Другое

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 and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.
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.
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.
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.
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.
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.
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.
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.
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.