Project Management Lead, R&D

Posting Date:Apr 19, 2024

Country:United States

State:New York

Location:Central Islip

Req Id:84016

Central Islip, NY:

hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to relevant stakeholders. Maintain effective and pro-active communication and coordination of activities with multi-functional internal and external stakeholders.

Qualifications and Requirements:

• Applicant must have a Master's Degree in Project Management, Pharmaceutical Sciences, or Business and Science and three (3) years of work experience in Pharmaceutical Manufacturing.
• Must have a detailed understanding of product development including effective scheduling, estimating, and workflow processes in a generic pharmaceutical environment.
• Applicant must have strong knowledge of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products.
• Experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs) is a must.
• Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a must.
• Must be able to prioritize assigned development of multiple projects.
• Experience with project governance practices is a must.
• Strong knowledge of Clean- In- Place and Sterilization- In- Place techniques and cleaning procedure for equipment using Cleaning Development Protocols.
• Demonstrate acceptable skills in oral and written communications, independent judgment, teaching and training, problem solving/decision making, adhering to timelines, negotiation skills, integrity, and adaptability.

40 hours per week: M-F. 9am-5pm. Must have proof of legal authority to work in the United States. Travel Required Infrequent/Domestic less than 10%. Salary $129,688.00-$130,000.00 per year.