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hims & hers

Connects patients to online medical care

Manager Technical Services

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeNew Albany, OH, USAIn-person

About the Job

Requirements

  • A Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related technical or scientific field is required.
  • At least 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 the site, FDA's Process Validation Guidance (2011), and current Good Manufacturing Practice requirements.
  • Experience supporting root-cause investigations and corrective and preventive actions in a regulated manufacturing environment.
  • Strong technical writing skills, including the ability to author clear, defensible protocols and reports.
  • Ability to work hands-on with manufacturing equipment and collaborate cross-functionally with Operations, Quality, and Engineering.

Responsibilities

  • 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 of 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 of Technical Services, and support related investigations.
  • 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 and 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 of Technical Services.
  • Support and execute technology transfer of new products, formulations, and processes into the site, including transfers from research and development or other manufacturing sites.
  • Coordinate site-level activities against transfer protocols, ensuring critical process parameters and acceptance criteria are met during transfer runs.
  • Partner with Research and Development, Quality, and Operations to document a smooth, well-supported transition from transfer to routine commercial production at the site.
  • 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.
  • 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 active pharmaceutical ingredient 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.
  • Lead or support root-cause investigations for process-related deviations, yield losses, and quality issues at the site.
  • Drive corrective and preventive actions to closure, and verify the effectiveness of implemented changes.
  • Maintain clear, defensible investigation documentation suitable for internal review and regulatory inspection.
  • 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 the site's process verification, cleaning validation, technology transfer, and troubleshooting history, and support technical responses to observations tied to process, cleaning, or equipment performance.
  • Lead, coach, and develop the site's Technical Services team, set clear priorities, and hold the team accountable for the quality, timeliness, and safety of its work.
  • Own hiring, onboarding, performance management, and career development for direct reports, in partnership with Human Resources.
  • Plan team workload and capacity across process verification, cleaning validation, technology 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.
  • Support scale-up and process definition activities for new products transitioning from Research and Development to the site.
  • Support installation and start-up activities for new capital equipment, including coordination with Engineering and vendors.
  • Support Installation, Operational, and Performance Qualification execution for new or upgraded equipment.
  • Support periodic requalification of equipment and processes according to site schedules and change control triggers.

Desired Qualifications

  • Experience with peptide, oligonucleotide, or other complex active pharmaceutical ingredient manufacturing processes.
  • Hands-on experience with autoclaves, isolators, filling lines, or active pharmaceutical ingredient processing or purification equipment.
  • Experience supporting new equipment commissioning, Installation, Operational, and Performance Qualification execution, or site launch activities.
  • Prior experience supporting FDA or state board of pharmacy inspections.

About the Company

hims & hers

Connects patients to online medical care

Hims & Hers operates a consumer health platform that connects people with licensed providers for online consultations and ongoing care. Its Hims and Hers brands give customers access to services for hair loss, sexual health, mental health, skin care, and weight management, alongside prescription and nonprescription products. Providers assess patients and make treatment decisions, while the group coordinates digital records, follow-up, and fulfillment through owned and partner pharmacies. Revenue comes from product sales and subscriptions that combine recurring shipments with access to care. Hims & Hers was founded in 2017 and is headquartered in San Francisco, California.

Company size
1,001-5,000
Company stage
Post IPO Equity
Headquarters
San Francisco, California
Founded
2017

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