Project Manager (PM)

Job Description

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.

Located at our large molecule headquarters in RTP, North Carolina, the Project Manager serves as the primary customer liaison and strategic project leader through effective planning, communication, and oversight, while delegating technical execution and analytical documentation responsibilities to Operations.

• Ensure work is executed in compliance with GMP regulatory requirements, SOPs, and industry best practices ensuring audit readiness and regulatory excellence across all project phases.
• Serve as the main point of contact for customers, ensuring alignment between client expectations and internal execution.
• Translate customer needs into actionable project plans in collaboration with the operational teams.
• Lead planning and execution of complex, multiphase projects, ensuring delivery on scope, budget, and timelines.
• Provide timely and effective communication to impacted stakeholders across different functional areas.
• Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site.
• Manage project budgets with precision, ensuring alignment with financial forecasts and proactively addressing variances to maintain profitability.
• Maintain strict adherence to project scope, timelines, and deliverables; identify and document scope changes and ensure appropriate change control processes are followed.
• Provide direct supervision, coaching, and professional development for junior project leaders or coordinators; foster a culture of accountability, growth, and continuous learning.
• Monitor key performance indicators (KPIs) for project execution and client satisfaction, proactively addressing risks and variances; use data to drive continuous improvement and client retention.
• Serve as a senior escalation point for project-related issues, facilitating resolution through collaboration with internal stakeholders and clients.
• Lead the planning, execution, and delivery of complex, multi-phase projects, balancing scope, quality, timelines, and budget while managing risk and change effectively.
• Lead cross-functional teams in a matrix setting.
• Perform advanced risk assessments and develop contingency plans to mitigate project and operational risks.
• Support root cause investigations and troubleshooting activities, ensuring timely resolution of technical and operational challenges.
• Collaborate with the Commercial team to support proposal development, client presentations, and strategic growth initiatives.
• Support internal strategic and operational initiatives by managing timelines, coordinating cross-functional input, and ensuring timely execution of internal projects alongside client-facing responsibilities.

Requirements

• B.S. in Chemistry, Biochemistry, or related field with 5 years of project management experience; or Master’s degree in Chemistry, Biochemistry or related field with 3 years of project management experience; or PhD in Chemistry, Biochemistry or related field with 1 years of project management experience
• Practical and theoretical knowledge about the analytical development process of biologics: method development, qualification and validation, method transfer, release and stability studies, etc.
• Extensive GMP knowledge.
• Demonstrated leadership experience managing scientific teams and complex programs in a CRO, CDMO, cGMP, or biopharmaceutical environment required.
• Proven record of successful client consultation and project management.
• Excellent written and communication skills.
• Strong financial aptitude.

Other Desired Skills/Abilities

• Experience with quality management systems, ERP Systems (Microsoft Dynamic), and CRMs.
• PMP Certification preferred.
• Ability to adapt to changing project requirements.
• Experience leading cross-functional teams.
• Excellent organizational skills and ability to work and make sound quality decisions independently and quickly.

Reporting Structure

This job typically reports to:

• Director, Project Management North America

Note: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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