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13 дней назад

Manager, Manufacturing - 12 Hour PM (6:00pm - 6:30am) (Biotech)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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
Manager, Manufacturing - 12 Hour PM (Biotech): Managing and leading inspection and packaging production areas with an accent on cGMP compliance, staff supervision, production scheduling, and manufacturing process optimization. Focus on maintaining compliant operations, resolving equipment and process problems, coordinating cross-functional teams, and developing production staff on a rotating 12-hour overnight schedule.

Location: New Albany, Ohio, United States; onsite role supporting a rotating 12-hour overnight schedule from 6:00pm to 6:30am

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Manage and lead a small manufacturing production area or a section of a larger inspection and packaging facility.
  • Maintain production operations in full cGMP and CFR compliance, including reviewing reports, protocols, procedures, and SOPs.
  • Coordinate manufacturing processes, equipment maintenance, system revalidation, production scheduling, and change control.
  • Collaborate with QA/QC, PPIC, Clinical Manufacturing, Process Development, and Regulatory teams to complete production activities.
  • Hire, train, evaluate, coach, and develop staff while ensuring plant safety and effective team operations.
  • Support department planning, budgeting, goals, and interaction with regulatory authorities including the FDA.

Requirements

  • Doctorate degree; or a master's degree with 3 years of relevant industry experience; or a bachelor's degree with 5 years; or an associate's degree with 10 years; or a high school diploma/GED with 12 years in pharmaceutical, medical device, or biotechnology industries.
  • Direct people-management experience or leadership experience directing teams, projects, programs, or resource allocation.
  • Experience with regulatory requirements, cGMP compliance, non-conformance, CAPA, scheduling, and technical writing.
  • Strong managerial, communication, conflict-resolution, analytical problem-solving, project-management, coaching, and team-building skills.
  • Availability to work a rotating 12-hour overnight schedule: 3 days one week and 4 days the next.

Nice to have

  • Educational background in science, engineering, or business administration.
  • Experience with presentation skills, mentoring, counseling, and managing organizational change.

Culture & Benefits

  • Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
  • Retirement and savings plans with company contributions.
  • Potential annual bonus, stock-based long-term incentives, and paid time off.
  • Career development opportunities and a collaborative, science-based work environment.
  • Visa sponsorship for this role is not guaranteed.

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