Regulated Product Launch Project Manager (Pharma)

Paycom - ATS; Easton (MD); On-site; USD 77,000 - 84,000; Full time

Job summary

Aphena Pharma Solutions in Easton, MD is seeking a Project Manager to coordinate management activities for regulated products, including cost estimation and product master records, from contract through post-launch commercialization.

You will lead cross-functional teams across Operations, Engineering, Purchasing, QA and Tech Services; develop Phase I/II costs; prepare regulatory submissions; manage timelines and risks; coordinate tech transfer and validation activities.

Qualifications

• Strong knowledge and understanding of Pharmaceutical cGMP and/or medical device cGMP.
• Strong MS Word skills.
• Strong MS Excel skills.
• Good working knowledge of MS Outlook and PowerPoint.
• Demonstrated Project Management skills required.
• Specific knowledge of MS Project preferred.
• Demonstrated understanding of general business processes and principles is required.
• A minimum of 2 years of experience in a Project Management or similar position, preferably in a manufacturing environment.
• Cross-functional experience with knowledge of Operations and cost analysis strongly preferred.

Responsibilities

• Coordinate daily project management activities for regulated products from contract to commercialization.
• Develop Phase I and Phase II costs for products deemed feasible and coordinate sample production for initial customer evaluation.

Skills

Project management

Cross-functional teamwork

Cost analysis

Regulatory knowledge

Communication

Leadership

Education

High School Diploma or equivalent

Tools

MS Word

MS Excel

MS Outlook

PowerPoint

MS Project

Job description

Aphena Pharma Solutions in Easton, MD is seeking a Project Manager to coordinate management activities for regulated products, including cost estimation and product master records, from contract through post-launch commercialization.

You will lead cross-functional teams across Operations, Engineering, Purchasing, QA and Tech Services; develop Phase I/II costs; prepare regulatory submissions; manage timelines and risks; coordinate tech transfer and validation activities.