CMC Technical Project Management

The Technical Project Manager provides day-to-day operational management for CMC development programs. Working in close partnership with the CMC Program Leader who drives program strategy the project manager leverages their technical and project management expertise to serve as the operational hub for CMC program teams driving execution communication and accountability across process development analytical formulation quality supply chain and external partners. 

This role blends technical understanding of biopharmaceutical CMC development disciplines with strong project management and coordination skills. Candidates are required to have biopharmaceutical industry experience through CMC technical roles with project management responsibility or through program management roles with deep understanding of CMC development. 

Responsibilities 

Project Operations & Execution 

• Lead day-to-day operational management of CMC development activities in an outsourced environment. 

• Apply technical judgment to build robust plans anticipate risks manage deviations and respond to unforeseen challenges. 

• Build integrated CMC project plans maintain and track timelines dependencies and deliverables across CMC functions. 

• Ensure plans and timelines are executed as agreed. 

• Monitor progress against milestones identify critical path activities and proactively escalate issues. 

• Coordinate execution across internal technical teams and external partners (e.g. CDMO). 

Risk & Issue Management 

• Support identification tracking and communication of CMC program risks (technical regulatory and supply-related). 

• Maintain risk registers contingency plans and decision logs. 

• Support the Program Leader in evaluating alternative scenarios and recommending operational adjustments. 

Communication & Stakeholder Management 

• Manage day-to-day communication with internal stakeholders leadership and external partners. 

• Facilitate information flow between CMC teams and the Program Leader to ensure alignment and transparency. 

• Leverage technical background to help craft effective communications around complex CMC plans or issue resolution. 

• Prepare & maintain project dashboards timelines and progress reports for governance and program reviews. 

• Organize and facilitate CMC team meetings including agendas minutes action tracking and documentation. 

Budget & External Partner Management 

• Support contract-related activities including statements of work change orders and purchase orders. 

• Track CMC and CDMO budgets invoices and spend in alignment with approved financial plans. 

• Coordinate with finance legal and procurement to support external sourcing activities. 

Operational Excellence 

• Apply project management best practices to improve efficiency consistency and visibility of CMC execution. 

• Maintain and continuously improve planning tools tracking systems templates and communication processes. 

• Partner with the CMC Program Leader and functional leads to strengthen CMC project planning and governance. 

Qualifications :

Mandatory qualifications 

• 8-10 years of experience in the biopharmaceutical industry  

• Direct involvement in biopharmaceutical CMC development programs 

• As a designated project manager or in a technical role with significant project management responsibilities. 

• BS MS or PhD in a scientific or engineering discipline  

• E.g. Chemistry Biochemistry Chemical or Biomedical Engineering Pharmaceutical Sciences 

• Experience working with CDMOs/CROs 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 project management tools (e.g. MS Project Smartsheet 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) 

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. 

• Demonstrated ability to identify and manage risks develop mitigation plans and proactively address issues to maintain program momentum. 

• Formal project management training or certification (e.g. PMP) 

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. 

Remote Work :

No

Employment Type :

Full-time