Manager, Technical Services at Hims and Hers · LumiJobs

Responsibilities

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.
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.

Manager, Technical Services

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Hims and Hers

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