Senior Technical Project Manager - CMC

• 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.

• 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.

• 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.

Sia