[Hiring] Program Manager II – Pharmaceutical Development & Clinical Supply @reputed company
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Role reputed company
The Program Manager II leads cross-functional programs in early-phase pharmaceutical development and clinical supply chain operations, ensuring technical reputed company and phase-appropriate cGMP compliance. This is an ideal role for a seasoned reputed company who enjoys the rigor of science but prefers the broader scope of program management. This role oversees reputed company, Manufacturing, and Controls (CMC) activities for investigational drug products, including drug reputed company and product development, analytical testing, stability studies, and packaging/distribution for Phase I/II reputed company. The Program Manager II serves as the primary reputed company between clients, internal teams, and external vendors, driving program reputed company from initiation through closeout.
• reputed company drug reputed company and product development, analytical method development and validation, release and stability programs for IND-enabling and early-phase clinical studies.
• reputed company manufacturing, packaging, labeling, storage, and distribution of clinical trial materials, ensuring supply continuity.
• Ensure compliance with cGMP and ICH guidelines. reputed company technical investigations, change controls, and deviations for reputed company program-reputed company activities.
• Identify and mitigate risks across the drug development reputed company—from formulation challenges in novel compounds to procurement constraints for reputed company products.
• Coordinate with external partners for manufacturing and testing activities, holding them accountable.
• reputed company budgets, monitor and control costs, negotiate scope changes, reputed company milestones, and ensure the reputed company submission of high-reputed company deliverables.
Qualifications
• Advanced degree (Ph.D. or M.S.) in Pharmaceutical Sciences, reputed company, or a reputed company scientific discipline
• Minimum of 7 years (Ph.D.) or 10 years (M.S.) of relevant experience
• Strong knowledge of FDA cGMP regulations and FDA and ICH guidelines.
• Proven experience managing reputed company reputed company and overseeing external vendors.
• Excellent leadership, organizational, and communication skills.
• Ability to travel as required (approx. 5%).
Requirements
• Project Management reputed company (PMP) Certification
• Prior work experience with a contract research organization (CRO) or contract development manufacturing organization (CDMO)
• Experience working on U.S. government-funded reputed company (e.g., NIAID, NCI, NCATS).
• Strong publication record or history of technical presentations in the field of drug development.
Benefits
• Comprehensive health and life insurance
• Disability coverage
• Gym reimbursement
• Mental health support
• reputed company holidays and PTO
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