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ICON is looking for a CMC Project Manager I to join our Accelerated Pharmaceutical Solutions department located in San Antonio, TX. In this role the project manager will be in the responsible of overseeing CMC projects, ensuring smooth coordination between internal teams, sponsors, and vendors. The successful candidate will drive project execution, mitigate risks, and ensure compliance with global regulatory requirements, contributing to the rapid advancement of pharmaceutical solutions, mostly in support of early phase drug product development. You will collaborate with the team to develop and validate manufacturing processes and analytical methods. To effectively communicate progress of awarded work to the client and liaise with lab operations on all aspects of the work. To keep accurate projections of work to be performed each month, perform billing for all analyses, and process change orders as required.
Job Responsibility:
Lead and manage multiple CMC projects from early development through commercialization
Coordinate cross-functional teams, including Analytical, Formulation Development, Manufacturing, Regulatory, and Quality Assurance
Review and authoring of relevant method validation, pharmaceutical analysis, QC reports and other relevant GMP documentation and deliverables
Develop and maintain detailed project plans, timelines, and risk assessments
Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines
Act as the primary liaison between clients, internal teams, and third-party vendors to ensure alignment and timely execution of project deliverables
Work with planning to ensure that appropriate resources are available to complete the study to timeline
Provide clear, timely, and professional communication to stakeholders regarding project progress, milestones, and potential challenges
Monitor project budgets and resource allocation to ensure efficient and cost-effective project execution and draft change order budget when scope changes occur
Support regulatory submissions by providing CMC-related documentation and guidance
Requirements:
A minimum of 1 year experience in clinical, laboratory or project management role
Background in project management, preferably in a pharmaceutical setting
Familiarity with GMP regulations and compliance requirements
Excellent communication and interpersonal skills
Ability to effectively manage resources and prioritize tasks to meet project deadlines
Detail-oriented with strong organizational and problem-solving abilities
Bachelor or advanced degree in a relevant scientific field preferred, e.g. medicinal chemistry, organic chemistry, pharmaceutical sciences
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others