Rebalancing the Regulatory Perimeter: How U.S…
Consulting
Senior 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.
Job description
Provide consulting services for Sia/LBG’s clients including, but not limited to:
- Routinely provide strategic oversight to maintain alignment of project milestones to day-to-day activities.
- Responsible for content, quality, and distribution of project management deliverables (reports, dashboards, etc.) and routine updates (schedule, budget, risk), typically as the final reviewer.
- Establish strong working relationships with leadership and project functional teams across all levels.
- Serve as project spokesperson and facilitate communications with all internal and external stakeholders (meetings, reports, etc.).
- Work with cross-functional teams (CMC, Med. Affairs/Clinical, Nonclinical, Quality, Regulatory, Finance, Legal, Contracts Management, etc.) to drive project activities against scheduled timelines, approved scope, and approved budget.
- Manage project financials including vendor invoice review/approval, budget development, actuals tracking, maintenance of time-phased financial forecast, preparation of project financial reports for internal and external stakeholders.
- Proactively manage strategic risks and issues, providing expertise in the identification and implementation of risk mitigation activities.
- Demonstrate and foster excellent teamwork, with the ability to navigate within multidisciplinary teams.
- Balance project demands to align/realign Budget, Quality, Timeline, and Scope, as needed.
- Lead product development meetings, and ensure all Project Leaders, and/or subteam leaders, have all the 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
- 8+ years of experience in the biopharmaceutical industry with a minimum of 5 years 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.
- Strong communication and interpersonal skills, with the ability to influence, collaborate, and build alignment across diverse technical and leadership teams.
- Proficiency in Planisware and principles to plan, manage, and track multiple parallel projects in a complex, matrixed environment.
- Fluent and articulate communication in English (written and spoken).
- Excellent written and oral communication, presentation, problem solving, and negotiation skills with an emphasis on building consensus.
- Ability to work independently and in collaboration with others.
- Flexibility and ability to deal with ambiguity, and sense of personal ownership of deliverables and results.
- Works well with teams, often comprised of multiple disciplines.
Ideal candidates
- Comprehensive 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).
- Strong understanding of product development lifecycle and pharmaceutical manufacturing operations.
- Strong 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.