CMC Project Manager I EDS

ICON plc • San Antonio, TX

2d • Hybrid

About The Position

Lab analyst ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development CMC Project Manager I- San Antonio Tx- Hybrid 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.

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.

Responsibilities

• 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.
• Proactively identify and address potential project risks, implementing effective mitigation strategies.
• 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.

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include: 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees