Director, Technical Services

🕒 Agosto 24

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $195.000 - $215.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 2%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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hims & hers

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2017

🏥 Saúde

💼 Consultoria

📣 Marketing

Healthcare • Consulting • Marketing

A Hims & Hers é uma plataforma de saúde 100% online que fornece atendimento personalizado e consultas para saúde sexual, crescimento capilar, perda de peso, cuidados com a pele e saúde mental. Com mais de 2 milhões de assinantes, a Hims & Hers conecta pacientes a profissionais de saúde licenciados, oferecendo medicamentos prescritos e suporte contínuo entregues diretamente em suas casas. A plataforma tem como objetivo tornar o atendimento médico acessível, econômico e discreto, garantindo que os usuários possam gerenciar seu tratamento convenientemente através de um aplicativo.

Descrição

• Lead technology transfer of new products, formulations, and processes into and between sterile and nonsterile compounding, 503B, and peptide API manufacturing sites • Own transfer protocols and reports, defining critical process parameters, in-process controls, and acceptance criteria • Coordinate with R&D, Quality, and Operations for transitions into routine commercial production • Own the multi-site cleaning validation program, including method development, worst-case grouping, sampling strategies, and acceptance-limit calculations • Author and execute cleaning validation protocols and reports and manage ongoing cleaning verification/monitoring • Lead process validation for sterile and nonsterile compounded preparations, sterile manufacturing, and peptide API manufacturing • Own the network-wide process validation program and ensure site verification remains aligned to the validated state • Diagnose and resolve process deviations, yield losses, quality issues, and equipment performance problems across four sites • Lead root-cause investigations, CAPAs, and continuous improvement projects • Support equipment commissioning, qualification, start-up troubleshooting, and reliability improvements • Set network-level strategy and standards for process development scale-up, capital equipment installation, and Equipment IOQ/PQ execution • Review and approve site IOQ/PQ and requalification protocols • Track requalification schedules and change-control triggers • Manage, coach, develop, hire, onboard, and plan career development for site Technical Services Managers • Establish network-wide technical standards, training, and knowledge-sharing forums • Participate in FDA and state board of pharmacy inspections as a technical subject matter expert • Provide inspection documentation and support technical responses to observations

🎯 Requisitos

• 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 • Direct, hands-on ownership of technology transfer, cleaning and process validation, or process/equipment troubleshooting • Demonstrated expertise across at least two of: 503A/503B compounding operations, sterile injectable manufacturing, and API/peptide manufacturing or process chemistry • Working knowledge of USP <795>, <797>, and <800> • Working knowledge of FDA's Process Validation Guidance (2011) • Working knowledge of ICH Q7/Q11 for API manufacturing • Strong root-cause investigation and CAPA experience • Experience resolving process and equipment issues in a regulated manufacturing environment • Ability to work across geographically distributed sites, including remote team collaboration and site travel • Strong technical writing skills • 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 • Experience with peptide, oligonucleotide, or other complex API manufacturing and associated technology transfers preferred • Hands-on equipment troubleshooting experience with autoclaves, isolators, filling lines, or API processing/purification equipment preferred • Experience supporting new equipment commissioning or site launch activities preferred • Prior FDA inspection participation, including front-room or back-room technical support, preferred • Legally authorized to work in the U.S. without restriction for any employer

🏖️ Benefícios

• Competitive salary • Equity compensation • Unlimited PTO • Company holidays • Quarterly mental health days • Medical, dental, and vision benefits • Parental leave • Employee Stock Purchase Program (ESPP) • 401(k) with employer matching contribution • Offsite team retreats • Flexible/remote work approach