Rebalancing the Regulatory Perimeter: How U.S…
Consulting
Technical Project Manager -CMC
Mount Street Lower, Dublin, Irlande
Company description
Sia is a global management and AI-focused consulting firm with a strong presence in the energy and utilities sector. With €500m in annual revenue and 3,000 employees worldwide, around 20% of our business is focused on energy and utilities.
Founded in France over 25 years ago, Sia has grown rapidly and is now a recognised leader in energy transition, data science and AI solutions. In 2024, we announced a strategic partnership with Blackstone as our first external investor, supporting our continued growth.
Sia’s Life Science and Healthcare Business Unit, Sia/LBG, focuses on supporting the life sciences and healthcare industries with strategic consulting, product development and non-dilutive funding expertise. This consulting division works with healthcare organizations, pharmaceutical & biotech companies, CROs, academia, medical device/diagnostic companies, and non-governmental organizations (NGOs) alike to solve complex business, scientific, regulatory, technological and product development challenges. Our subject matter experts help advance our clients’ products and projects; supporting these companies - both large and small - to achieve organizational objectives and create tangible value for their stakeholders.
Why join the Sia Village?
Excellence | Entrepreneurship | Innovation | Teamwork | Care & Support | Employee Wellbeing
These are the six core values that guide all our actions.
Your experience at Sia will be enriched by a(n):
- Entrepreneurial journey
- Support with achieving professional development goals through guidance and real-time feedback
- Continuous learning & development opportunities
Job description
The CMC Technical Project Manager provides day-to-day operational management for CMC development and technical transfer projects. Working in close partnership with the CMC Technical Senior Project Manager who leads project management activities, the CMC Technical Project Manager leverages their technical and project management expertise to serve as the operational hub for CMC project teams, supporting execution and communication across process development, analytical, formulation, quality, supply chain, and external partners.
This role blends technical understanding of biopharmaceutical CMC development disciplines with project management and coordination skills. Candidates are required to have biopharmaceutical industry experience through CMC technical roles with project management responsibility or through project management roles with understanding of CMC development.
Responsibilities
Provide consulting services for Sia/LBG’s clients including, but not limited to:
- Routinely provide tactical support for day-to-day project activities such as meeting minutes, action tracking/follow-up, decision tracking, etc.
- Actively contribute to project management deliverables (reports, dashboards, etc.) and routine updates (schedule, budget, risk), typically preparing initial drafts.
- Build and maintain detailed predecessor-driven project schedules (Gantt charts, integrated timelines) utilizing scheduling tools/software (e.g., MS Project, Smartsheet, Planisware, Primavera, or equivalent).
- Provide clear and timely schedule updates, variance analyses, and risk assessments to project leaders and stakeholders to ensure project schedules remain aligned with project strategy, portfolio priorities, and key decision gates (e.g., regulatory submissions, health authority interactions).
- Coordinate across project functional areas and personnel as required to ensure progress of project activities.
- Support the building and management of a team representing various functions and sites, including the management of multiple projects and teams across multiple locations.
- Demonstrate and foster excellent teamwork, with the ability to navigate within multidisciplinary teams.
- Balance project demands to support alignment/realignment of Budget, Quality, Timeline and Scope, as needed.
- Support product development meetings, and make sure all Project Leaders, and/or subteam leaders, have all information and support needed to implement the project.
- Focus on customer service, with agility and clear communication.
- Adhere to Sia/LBG quality standards regarding client deliverables.
Qualifications
Mandatory qualifications
- At least 2 years of experience in the biopharmaceutical industry with a minimum of 1 year of project management experience.
- BS, MS, or PhD in a scientific or engineering discipline
- E.g., Chemistry, Biochemistry, Chemical or Biomedical Engineering, Pharmaceutical Sciences.
- Experience working with CDMOs to support outsourced development and manufacturing activities, including oversight of deliverables and timelines.
- Ability to engage in technical and scientific discussions.
- Good communication and interpersonal skills.
- Proficiency in Planisware.
- Fluent and articulate communication in English (written and spoken)
- Good written and oral communication, presentation, problem solving and negotiation skills.
- Ability to work independently and in collaboration with others.
- Flexibility and ability to deal with ambiguity, and a strong sense of personal ownership of deliverables and results.
- Works well with teams, often comprised of multiple disciplines.
Desirable Qualifications
- Broad understanding of CMC, including:
- Small molecule, biologics, or vaccine formulation, process development, analytical development, and GMP manufacturing across both early and late-stage development.
- Formal project management training or certification (e.g., PMP).
- Understanding of product development lifecycle and pharmaceutical manufacturing operations.
- Understanding of cGXP guidelines and regulatory requirements.
Additional information
Sia is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.