Назад
Company hidden
8 дней назад

Manager, Manufacturing Science & Technology

Формат работы
remote (Global)
Тип работы
fulltime
Грейд
senior
Английский
b2
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Manager, Manufacturing Science & Technology (Biotechnology and GMP Manufacturing): Leading technology transfer, process monitoring, validation, and commercial-scale GMP manufacturing support for drug substance and drug product operations with an accent on process compliance, quality standards, and cross-functional execution. Focus on coordinating process start-up activities, closing deviations, managing change controls, and supporting process characterization and PPQ activities.

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings, events, and visits to CDMO sites is expected, with travel of up to 40%. Candidates located on the East Coast, particularly in Ohio, Massachusetts, and Rhode Island, are strongly encouraged to apply.

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

  • Lead and execute end-to-end technology transfer activities from process development through commercial-scale GMP manufacturing.
  • Conduct facility fit assessments and coordinate process start-up activities.
  • Review batch records, SOPs, raw material specifications, development reports, and GMP protocols.
  • Provide real-time, in-plant support during production campaigns while monitoring process parameters and quality standards.
  • Trend process data, support process improvements, and drive closure of process deviations in Veeva.
  • Support change controls, process comparability assessments, process characterization, PPQ activities, SOW reviews, and supply chain risk mitigation.

Requirements

  • Bachelor’s degree in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or a related field.
  • At least 5 years of relevant experience.
  • Technical background in drug substance operations, including upstream cell culture and/or downstream purification, and/or drug product operations.
  • Hands-on experience with GMP manufacturing, process validation, and technology transfer teams.
  • Strong verbal and written communication, interpersonal, and cross-functional collaboration skills.
  • Ability to work independently in a fast-paced, multidisciplinary environment while working remotely.

Nice to have

  • Expertise in drug product fill processes.

Culture & Benefits

  • Fully remote work with purposeful opportunities for in-person collaboration.
  • Medical, dental, vision, and mental health support, plus an annual wellbeing reimbursement.
  • Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
  • 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
  • Learning programs, LinkedIn Learning access, mentorship, employee resource groups, and service opportunities.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →