Project Manager II

Requirement/Must Have:

• Bachelor s or Master s degree in Chemistry, Pharmacy, Life Sciences, or related field.
• Minimum 7 years of experience in technical project management, pharmaceutical development, technical operations, or manufacturing.
• Strong experience managing small molecule development or drug product dosage forms.
• Demonstrated ability to lead and facilitate cross-functional, multi-disciplinary teams.
• Strong understanding of CMC development and lifecycle management.
• Experience in coordinating with external partners such as CMOs and CROs.
• Strong organizational, communication, and presentation skills.
• Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, and Project.
• Ability to manage timelines, milestones, and project deliverables effectively.

Experience:

• Experience in technical project management within pharmaceutical or life sciences environments.
• Experience supporting manufacturing and supply operations and lifecycle management programs.
• Experience working with international project teams preferred.
• Experience with quality and regulatory processes highly desirable.
• Experience managing external manufacturing or contract research organizations preferred.

Responsibilities:

• Coordinate technical project activities across MSAT, Manufacturing and Supply, R&D, regulatory, and commercial teams.
• Manage relationships with CMOs and CROs, including reviewing proposals, reports, and technical data.
• Organize and maintain technical documentation and project-related information.
• Provide technical support to manufacturing sites and assist in resolving deviations and improving process robustness.
• Assist in reviewing contracts, agreements, and quotations related to development and manufacturing projects.
• Support execution of technical strategies related to synthetic process and pharmaceutical development.
• Implement product control strategies aligned with regulatory and quality requirements.
• Conduct risk assessments and develop contingency plans for project activities.
• Draft technical reports and documentation supporting lifecycle management.
• Assist in preparing and reviewing protocols, reports, and regulatory submission content.
• Develop and maintain detailed project plans, timelines, and milestones.
• Organize and lead project meetings, track action items, and ensure adherence to timelines.
• Communicate project updates to stakeholders, including internal teams and external partners.

Should Have:

• PhD in Chemistry or related field preferred.
• Experience in Quality by Design methodologies preferred.
• Experience with regulatory submissions and dossier preparation preferred.
• Experience working with alliance partners and external manufacturing teams preferred.

Skills:

• Technical project management.
• Pharmaceutical development.
• CMC lifecycle management.
• Small molecule development.
• Manufacturing and supply coordination.
• CMO and CRO management.
• Risk assessment and mitigation.
• Regulatory and quality compliance.
• Project planning and scheduling.
• Stakeholder communication.
• Technical documentation.
• Microsoft Office tools.