1 день назад
Entry Level Associate Project Manager: Biopharmaceutical Product Testing (GMP)
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Описание вакансии
Текст:
TL;DR
Entry Level Associate Project Manager: Biopharmaceutical Product Testing (GMP): Planning and coordinating GMP-compliant biopharmaceutical testing projects in a regulated laboratory environment with an accent on project delivery, client communication, financial tracking, and regulatory compliance. Focus on monitoring schedules and risks, managing cross-functional stakeholders, supporting audits and investigations, and ensuring testing deliverables meet FDA, EMA, and ICH requirements.
Location: Onsite in Lancaster, PA, USA; hybrid work may be available after the first year. Candidates must live within a commutable distance of Lancaster and be authorized to work in the United States indefinitely without restriction or sponsorship.
Company
provides analytical testing and laboratory services across pharmaceutical, food, environmental, cosmetic, genomics, and related life sciences markets.
What you will do
- Lead multiple GMP testing projects from initiation through closure.
- Maintain project schedules, action trackers, dashboards, turnaround-time metrics, and schedule variance reports.
- Monitor risks, implement mitigation plans, and ensure deliverables meet client and regulatory requirements.
- Act as the primary client contact and facilitate project meetings, technical visits, status calls, and business reviews.
- Track project financial performance, including utilization, planned versus actual hours, budget variance, and cash flow.
- Coordinate with Operations, QA, Sample Registration, Pricing, Business Development, partner sites, and subcontractors.
Requirements
- Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field.
- Indefinite authorization to work in the United States without restriction or sponsorship.
- Knowledge of GMP regulations, including 21 CFR Part 210/211 and EU GMP, as well as GLP and relevant quality standards.
- Background in pharmaceutical sciences, analytical chemistry, or biologics; GMP laboratory or CMC testing experience is preferred.
- Strong project management, organization, time-management, communication, and stakeholder-management skills.
- Proficiency with project management tools such as MS Project and Smartsheet.
Culture & Benefits
- Full-time Monday-Friday schedule, 8:00 a.m.-5:00 p.m., with overtime as needed.
- Onsite work in Lancaster with a potential hybrid option after the first year.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- 401(k) with company match, paid vacation, and paid holidays.
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