Project Manager

7 hours ago


Ahmedabad, Gujarat, India Zydus Lifesciences Full time

Role & responsibilities

Project Management: -

  • Lead end-to-end project lifecycle: initiation, planning, execution, monitoring, and closure.
  • Develop integrated project plans across workstreams (drug substance, drug product, analytical, regulatory, quality).
  • Coordinate cross-functional teams including internal departments, vendors, and external stakeholders.
  • Conduct scenario planning, risk assessments, and mitigation strategies.
  • Manage project meetings, documentation, and stakeholder communications.

Manufacturing & CMC Oversight

  • Oversee Chemistry, Manufacturing, and Controls (CMC) activities across vaccine development phases.
  • Support tech transfer, scale-up, validation, and lifecycle management.
  • Ensure GMP compliance and readiness for audits and regulatory submissions.

Strategic & Financial Management

  • Align projects with organizational strategic goals and KPIs.
  • Manage budgets, forecasts, and financial reporting.
  • Track expenditures and ensure cost-effective delivery.

Regulatory & Quality Integration

  • Coordinate preparation of CMC sections for regulatory filings (IND, IMPD, BLA).
  • Interface with regulatory bodies and respond to Health Authority queries.
  • Implement CAPA and quality assurance measures.

Workforce & Ecosystem Development (Optional for R&D-focused roles)

  • Support training programs, internships, and workforce development initiatives.
  • Organize vaccinology courses, webinars, and collaborative events.

Preferred candidate profile

Qualifications:

  • Bachelors degree in a scientific field (e.g., Biology, Pharmacy, Chemistry); Master's or PMP certification preferred.
  • 7–12 years of experience in vaccine/biologics project management, manufacturing, or R&D.
  • Experience with CDMOs, CROs, and global health organizations.
  • Proficiency in project management tools (MS Project, Smartsheet, SharePoint).
  • Strong leadership, communication, and stakeholder management skills.

Desirable Skills:

  • Knowledge of Six Sigma/DMAIC methodologies.
  • Knowledge of SAP/HANA
  • Experience in strategic planning and governance.
  • Ability to manage international collaborations and multicultural teams.


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