Manager, Technical Services

Hims & Hers•Mesa, AZ
•$145,000 - $170,000

About The Position

The Manager, Technical Services is the site-level technical owner for process verification, cleaning validation, and technology transfer at an assigned Hims & Hers facility. The role drives process optimization and resolves equipment and process issues to support reliable day-to-day manufacturing, while also supporting process development, capital equipment installation, equipment qualification, and requalification as the site grows. The position reports to the Director, Technical Services and works closely with site Operations, Quality, Engineering, and Maintenance. The role leads and develops the site's Technical Services team, including setting priorities, managing workload and capacity, hiring, onboarding, performance management, and career development. It supports regulatory inspections as a technical subject matter expert and maintains clear documentation suitable for internal review and regulatory inspection. Site responsibilities span sterile and nonsterile compounding and manufacturing activities, as applicable to the assigned facility.

Requirements

  • Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related technical or scientific field.
  • 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 cGMP requirements.
  • Experience supporting root-cause investigations and CAPA in a regulated manufacturing environment.
  • Strong technical writing skills and ability to author clear, defensible protocols and reports.
  • Comfort working hands-on with manufacturing equipment and collaborating cross-functionally with Operations, Quality, and Engineering.

Nice To Haves

  • 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.

Responsibilities

  • Execute process verification activities for compounded preparations and manufacturing processes, confirming critical process parameters and in-process controls are consistently met.
  • Author and execute process verification protocols and reports, and maintain supporting data packages for audits and inspections.
  • Identify process drift or emerging trends, raise them 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 accordance with network standards 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 site's ongoing cleaning verification and monitoring schedule.
  • Assess cleaning validation impacts from new products, equipment changes, or campaign changes and escalate revalidation needs to the Director, Technical Services.
  • Support and execute technology transfer of new products, formulations, and processes into the site, including transfers from R&D or other manufacturing sites.
  • Coordinate site activities against transfer protocols and ensure critical process parameters and acceptance criteria are met during transfer runs.
  • Partner with R&D, Quality, and Operations to document the transition from technology transfer to routine commercial production.
  • Identify and lead site-level continuous improvement projects to increase process robustness, throughput, and consistency.
  • Analyze process and yield data, identify optimization opportunities, and implement changes through the site's change control process.
  • Work with Operations to incorporate 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, and unexpected results involving compounding, filling, sterilization, or API processing equipment.
  • Partner with site Engineering and Maintenance to identify equipment-related root causes and implement reliability improvements.
  • Support commissioning and start-up troubleshooting for new or upgraded equipment during qualification and launch phases.
  • Lead or support root-cause investigations for process-related deviations, yield losses, and quality issues.
  • Drive corrective and preventive actions (CAPA) 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, provide site documentation on process verification, cleaning validation, technology transfer, and troubleshooting history, and support technical responses to related observations.
  • Lead, coach, and develop the site's Technical Services team, setting priorities and holding the team accountable for quality, timeliness, and safety.
  • 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, technology transfer, and troubleshooting activities to meet production and compliance timelines.
  • Build the team's technical capability through training, mentorship, and knowledge-sharing on validation practices and equipment troubleshooting.
  • Support process development, including scale-up and process definition for new products transitioning from R&D to the site.
  • Support installation and startup of new capital equipment, coordinating with Engineering and vendors.
  • Support Installation, Operational, and Performance Qualification (IOQ/PQ) execution for new or upgraded equipment.
  • Support periodic requalification of equipment and processes according to site schedules and change control triggers.

Benefits

  • Competitive salary and equity compensation for full-time roles.
  • Unlimited PTO, company holidays, and quarterly mental health days.
  • Comprehensive health benefits including medical, dental, and vision coverage, and parental leave.
  • Employee Stock Purchase Program (ESPP).
  • 401(k) benefits with employer matching contribution.
  • Offsite team retreats.
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