- Reference: GY43877
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Using project management knowledge within the drug development industry, the Associate Manager plans, coordinates and leads the progress of assigned CMC Projects of moderate scope as established by defined milestones and objectives.
- Functions as a liaison or lead between Global CMC Project Management and production functional areas in order to facilitate the advancement of Drug Substance Manufacturing Projects. Provides support to the Global CMC PM team and supervisor in assessing resource needs to achieve project timelines and quality milestones.
- Creates, maintains and executes CMC Project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools required to facilitate planning and coordination of deliverables for each assigned CMC Project.
- Ensures effective, accurate and timely communication across functional areas and partners within the CMC Project/Program, serving as a primary point of contact among functional areas for CMC Project-related issues. Communication responsibilities include but not limited to CMC Project mtg, Global CMC meetings, Manage Supply, and weekly/monthly project updates.
- Assesses CMC Project issues and develops solutions to meet productivity and quality milestones and objectives. Develops tools and mechanisms for monitoring progress and problem solving with CMC Project and functional area managers. Defines and documents working / best practices that can be used across other CMC Projects with all relevant departments in order to ensure that product is efficiently supplied.
- Serve as liaison between the RAH-IOPS site and all Global CMC project team members.
- Coordinate the CMC regulatory activities required for submission of license applications, INDs, and other regulatory documents to government agencies in clear alignment with the Global CMC Project Plan.
- Lead special projects as assigned by supervisor/department management.
Skills, Experience and Qualifications:
- Requires BSc/BEng in scientific discipline or related field with 7+ years of relevant work experience in pharmaceutical or related industry.
- 3+ years of related project management experience in a GMP environment desirable
- PMP certification or MBA a plus.