4 дня назад
Manager, Project Management - Large Molecule (Biologics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Project Management - Large Molecule (Biologics): Leading large-molecule development programs from research through technical operations, technology transfer, regulatory submission, and launch with an accent on cross-functional coordination, CDMO collaboration, and biologics risk management. Focus on planning milestones, driving process characterization and validation, managing comparability studies, and aligning drug substance, drug product, analytical development, quality, and regulatory teams.
Location: Hybrid role based out of the Bridgewater, New Jersey office; remote work is available most of the time, with in-person collaboration as needed. Occasional global travel of up to 20% is required.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Lead large-molecule project teams internally and with CDMOs and other external partners.
- Guide biologics programs from research through technical operations, technology transfer, regulatory submission, and launch.
- Coordinate Drug Substance, Drug Product, Analytical Development, Quality, and Regulatory functions around shared project goals.
- Establish structured frameworks for technology transfer, process characterization and validation, and comparability studies.
- Identify and mitigate biologics risks, including cell line stability, viral safety, and supply constraints.
- Own project plans, milestone tracking, communications, budget planning, resource forecasting, and governance updates.
Requirements
- Bachelor’s degree and at least five years of project management experience in large-molecule or biologics development.
- Working knowledge of upstream and downstream processing, drug product development, and fill-finish.
- Strong people and team leadership skills, including the ability to guide cross-functional teams without formal authority.
- Proficiency with project management and productivity tools such as MS Project, Excel, and PowerPoint.
- Ability to work from the Bridgewater, New Jersey office in a hybrid arrangement and travel globally up to 20%.
Nice to have
- PMP certification.
- Experience with monoclonal antibodies, recombinant proteins, or cell and gene therapy.
Culture & Benefits
- Medical, dental, vision, and mental health coverage.
- Annual wellbeing reimbursement and Employee Assistance Program access.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, service programs, and volunteer opportunities.
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