Director, Technical Services

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $195k - $215k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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hims & hers

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

🏥 Healthcare

💼 Consulting

📣 Marketing

Healthcare • Consulting • Marketing

Hims & Hers is an online platform with over 1 million subscribers that connects patients to licensed healthcare professionals across all 50 states in the U. S. The service offers comprehensive support for sexual health, weight loss, hair regrowth, mental health, and skincare through a 100% online process. Clients can receive personalized treatment plans which may include prescription medications, and benefit from free and discreet shipping. Hims & Hers prides itself on providing accessible and affordable healthcare without the need for insurance, offering transparent pricing and support from licensed providers. It aims to empower individuals by making healthcare and treatment conveniently available on their own terms, including mental health support, which includes treatments for anxiety and depression.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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