Role Summary
Oversees and leads projects in support of early programs Product Supply Chain Teams and Commercial Value Chain Teams, ensuring alignment with product strategy, and operationalize project plans timely completion, within budget, and to the required quality standards. This role involves planning, executing, and and overseeing multiple projects, managing teams, and collaborating with various stakeholders. Key responsibilities include developing project plans, collaborating cross-functionally to deliver on project goals, managing schedules, mitigating risks, ensuring compliance with regulations, share best practices and support continuous improvement initiatives.
Responsibilities
- Develop, manage, and execute detailed project plans, timelines, and resource allocation strategies aligned with product strategy.
- Coordinate multi-project planning, including scheduling and facilitating meetings, executing plans, and supporting life cycle management initiatives.
- Identify cross-project synergies and implement process optimizations to enhance efficiency.
- Monitor project costs and track spending to ensure adherence to budget.
- Maintain project schedules and proactively address delays or constraints.
- Identify potential risks and develop mitigation strategies to minimize impact.
- Resolve project issues through scenario analysis, escalation, and risk management practices.
- Lead and motivate project teams, fostering a culture of collaboration and execution excellence.
- Facilitate team meetings, including scheduling, agenda development, minutes, executive summaries, and action item follow-up.
- Promote effective communication across teams and stakeholders.
- Maintain strong relationships with stakeholders and governance forums.
- Prepare and deliver routine status reports, providing clear updates on project progress and key decisions.
- Ensure projects adhere to relevant regulations, standards, and quality requirements (e.g., GMP, FDA, ICH guidelines).
- Support development and implementation of best practices.
- Maintain accurate project documentation throughout the lifecycle.
- Provide regular progress reports and ensure transparency in project status.
- Oversee project closeout activities, including final reports, financial reconciliation, and lessons learned.
Qualifications
- Required: Bachelorโs degree in a relevant scientific, technical, or engineering discipline
- Preferred: A master's degree or relevant certifications (e.g., PMP)
Education
- Required: Bachelorโs degree in a relevant scientific, technical, or engineering discipline
- Preferred: A master's degree or relevant certifications (e.g., PMP)
Experience
- 4โ7 years of relevant experience, including at least 2+ years in a project management role (preferably in biotech, life sciences, or drug development).
- Deep understanding of biotech and drug product development lifecycle.
- Demonstrated experience managing complex projects in fast-paced, matrixed environments.
- Skilled in multi-project planning and coordination, with ability to identify synergies and optimize processes.
- Proven expertise in risk management, scenario analysis, and mitigation strategies and portfolio management.
- Strong track record in process optimization using methodologies such as Lean-DMAIC; Green Belt or higher certification is a plus.
- Ensure compliance with industry standards and regulations, including GMP, FDA, and ICH guidelines (8โ12).
- Ability to lead and motivate teams, manage conflicts, and foster collaboration and continuous improvement.
- Learning Agility: Quickly adapt to new information and changing priorities.
- Action Orientation: Drive results with a proactive, solution-focused approach.
- Exceptional verbal and written communication skills, with ability to engage stakeholders at all levels.
- Skilled in preparing status reports, executive summaries, and delivering clear project updates.
- Proficient in MS Office Suite (Word, PowerPoint); MS Project preferred.
- Strong analytical and problem-solving skills: ability to assess complex situations and develop effective solutions.
- Understanding of financial principles, including budgeting, cost control, and financial reporting.
Skills
- Project management
- Cross-functional collaboration
- Risk assessment and mitigation
- Process optimization (Lean-DMAIC)
- Regulatory compliance (GMP, FDA, ICH)
- Budgeting and financial reporting
- Strong communication and stakeholder management
- MS Office; MS Project knowledge
Additional Requirements