CMC Project Manager, R&D Pharma
We are now actively sourcing for a CMC Project Manager for a permanent opportunity who will use their strong technical drug product development background to support CMC teams within the development portfolio.
The successful candidate will work closely with the other pharmaceutical R&D areas, process development, manufacturing, supply chain, quality and regulatory to ensure execution of project plans to meet key corporate goals.
Responsibilities of CMC Project Manager, R&D Pharma:
• Play a key role in the management of cross functional activities within CMC teams, partnering closely with team members as well as members of R&D senior management to orchestrate development of CMC plans, timelines, budgets, and ensure execution of project plans to meet key corporate goals.
• Facilitates development of CMC project plans, including:
• Integration of detailed execution and long-term development plans across the various CMC areas such as: API development and manufacturing, formulation development, process development, analytical method development and validation, manufacturing, quality, and CMC regulatory
• Identification of critical program assumptions/activities/constraints
• Supports team with optimization of plans by evaluating assumptions and incorporation of new inputs as the projects progress through development
• Proactive management of project execution as well as potential risk areas and supporting mitigation and/or contingency plans
• Develops and maintains CMC program budgets and timelines, facilitates cross-functional logistics and manages project communications tools in order to provide up-to-date project information and documentation to the team and functional area management
Requirements for CMC Project Manager, R&D Pharma:
• BSc/MS in a scientific or engineering discipline, with 8+ years of relevant pharmaceutical product development experience.
• Prior experience managing cross functional teams with timeline management and budgetary responsibility.
• Prior experience working with regulatory submissions (IND submissions, etc.)
• Expert knowledge of MS Project and MS Excel.
• Exceptional verbal/written communication, time/resource management, attention to detail, interpersonal and organization skills.
• Values the team dynamic, is organizationally savvy, excels in a matrixed-management/leadership environment, and enjoys working on the details without losing site of the larger organizational goals.
For further details please contact; Larry on +353 (0) 1 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/