Job Responsibilities:
- Lead cross-functional biologics development programs (including biosimilars) from technology transfer through commercialization, ensuring alignment with strategic goals, and timelines.
- Drive business case approvals, develop project charters, and create integrated project plans to guide execution.
- Develop and manage detailed project schedules, track execution progress, and ensure delivery within defined scope and timelines.
- Monitor project lifecycle using tools such as MS Project, Office Timeline, and Smartsheet to ensure transparency and accountability.
- Manage technology transfers to and from third-party CMOs and internal sites, ensuring knowledge capture, documentation, and risk mitigation.
- Act as the primary liaison between the company and external partners (CMOs, CROs), ensuring effective communication and collaboration.
- Coordinate with cross-functional teams including Regulatory, Quality, Supply Chain, and Finance to ensure timely and successful program deliverables.
- Follow established governance structures and escalation matrices to resolve issues and maintain program momentum.
- Negotiate with service providers and CROs for program-related activities
- Ensure data package readiness for regulatory submissions and lifecycle management filings and support regulatory agency interactions.
- Develop systems and processes to enhance operational efficiency and support PMO initiatives.
- Drive MIS (Dashboards, Data integration,Power BI, MS Project, Smartsheet)and management reporting and promote project management best practices across cross-functional teams.
- Manage Integrated Risks for project, including tracking of all mitigations.
Key Program Management Capabilities:
- Strategic Planning & Execution:Ability to define program goals, develop integrated plans, and drive execution across multiple workstreams.
- Cross-Functional Leadership:Proven experience leading diverse teams across technical, quality, regulatory, and operational functions.
- Stakeholder Engagement:Strong interpersonal skills to manage internal and external stakeholders, including CMO partners and regulatory bodies.
- Risk & Issue Management:Skilled in identifying risks early, assessing impact, and implementing mitigation strategies.
- Change Management:Ability to manage change in a dynamic environment, including scope adjustments and resource reallocation.
- Communication & Reporting:Excellent written and verbal communication skills, with the ability to present complex information clearly to senior leadership.
- Budget & Resource Management:Experience managing program resource allocation, and vendor oversight.
- Tools & Methodologies Proficiency:
- Strong command of project management tools such as MS Project, Smartsheet, and Excel-based trackers.
- Familiarity with Stage-Gate, Agile, and Waterfall methodologies.
- Skilled in using dashboards, Gantt charts, risk registers, and KPIs to monitor progress and drive decision-making.
Qualifications:
- Bachelor s or master s degree in biotechnology, Biochemistry, Chemical Engineering, or related field. Advanced degree (MBA) is a plus.
- 8-12 years of experience as a program management in the pharmaceutical/biotech industry, which operates in development and manufacturing and marketing.
- Experience managing cross-functional programs involving CMO partnerships.
- Strong understanding of GMP, regulatory requirements, and biologics manufacturing processes.
- PMP certification or equivalent is desirable.
