- Expired: over a month ago. Applications are no longer accepted.
We are seeking a Project Manager to join our team! You will be responsible for managing the projects for the Generic small molecule Product Development, Manufacturing, and ANDA Submission. This includes ensuring on time and on budget delivery of projects and acting as a leadership role focal point between CMO /CRO and our technical team. This role involves managing the execution of our project requirements with CMO/CRO as per an agreed upon program of activities.
- Prepare and manage project plan to meet milestones.
- Proactively evaluate, highlight, and escalate unresolved issues, potential barriers to project progression, and resources constraints to management.
- Lead meetings to facilitate project completion.
- Deliver projects within the agreed upon timeline and budget.
- Communicate project status and highlight critical path activities in a timely manner to management and Business Development.
- Provide notification of milestone completions for billing to finance.
- Communicate with supplier, vendor or contractor on project requirements and expectations.
- Stay current with the regulatory requirements and industry trends for project management.
- Write plans, engineering drawings, business correspondence, and standard operating procedures.
- Effectively present information and respond to questions from groups of managers, customers, and regulatory agencies in writing and verbally.
- Perform all foregoing applying knowledge of project management principles and concepts in a cGMP environment within the pharmaceutical industry.
- Previous experience in pharmaceutical project management related fields preferred.
- Proficient with use of technologies (e.g. Adobe Acrobat, Power Point, Gantt Chart).
- Working experience in generic product development and ANDA submissions.
- Working knowledge of FDA regulations and applicable FDA guidance.
- Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines.
- Minimum BS in a scientific discipline, Chemistry, Chemical Engineering or a related discipline.
- 1+ year experience in pharmaceutical project management is required, 3-5 years pharmaceutical product development and/ or manufacturing experience is preferred.
- Bi-Lingual (English and Chinese Mandarin) preferred.
If interested, please send your resume to email@example.com
Praxgen Pharmaceuticals LLC
AddressMonmouth Junction, NJ
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