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6 часов назад

Director, Technical Services (Pharmaceutical Manufacturing)

195 000 - 215 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Director, Technical Services (Pharmaceutical Manufacturing): Leading technology transfer, cleaning validation, process validation, and process and equipment troubleshooting across a multi-site sterile, nonsterile, and peptide API manufacturing network with an accent on validation strategy, regulatory readiness, and manufacturing reliability. Focus on managing site Technical Services Managers, resolving complex process and equipment deviations, and supporting FDA and state board of pharmacy inspections.

Location: US Remote; role is intended for US-based candidates

Salary: $195,000–$215,000 annual base compensation, plus potential equity

Company

Hims & Hers operates a health and wellness platform and is expanding a multi-site network of sterile and nonsterile compounding pharmacies, a 503B outsourcing facility, and a peptide API manufacturing site.

What you will do

  • Define and lead the multi-site Technical Services strategy across sterile, nonsterile, and peptide API manufacturing operations.
  • Lead technology transfers for products, formulations, and processes, including transfer protocols, reports, process parameters, controls, and acceptance criteria.
  • Own cleaning and process validation programs, including protocols, sampling plans, acceptance limits, process qualification, and continued process verification.
  • Diagnose process deviations, yield losses, quality issues, and equipment problems; lead root-cause investigations, CAPAs, and continuous improvement initiatives.
  • Oversee equipment IOQ/PQ, requalification, commissioning, start-up troubleshooting, and site-level technical programs.
  • Manage, coach, and develop Technical Services Managers while supporting FDA and state board of pharmacy inspections as a technical subject matter expert.

Requirements

  • Bachelor’s degree in Engineering, Pharmacy, Chemistry, or a related technical or scientific field; an advanced degree is preferred.
  • 12+ years of progressive experience in pharmaceutical manufacturing or sterile/nonsterile compounding with hands-on ownership of technology transfer, cleaning validation, process validation, or process and equipment troubleshooting.
  • Expertise in at least two of the following: 503A/503B compounding, sterile injectable manufacturing, and API or peptide manufacturing/process chemistry.
  • Working knowledge of USP <795>, <797>, <800>, FDA Process Validation Guidance, and ICH Q7/Q11.
  • Strong root-cause investigation, CAPA, technical writing, and protocol/report review skills.
  • Experience managing or developing managers or supervisors across geographically distributed manufacturing sites, including remote collaboration and site travel.

Nice to have

  • Experience with peptide, oligonucleotide, or other complex API manufacturing and technology transfers.
  • Hands-on troubleshooting of autoclaves, isolators, filling lines, or API processing and purification equipment.
  • Experience with new equipment commissioning, site launches, and FDA inspection support.

Culture & Benefits

  • Equity compensation and Employee Stock Purchase Program.
  • Unlimited PTO, company holidays, and quarterly mental health days.
  • Medical, dental, vision, and parental leave benefits.
  • 401(k) with employer matching contribution.
  • Offsite team retreats and a flexible remote work approach.
  • Focus on ethics, wellness, inclusion, and belonging.

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