Pharmaceutical Project Manager – Cell & Gene Therapy
baltimore, MD
Contracted
Mid Level
MEDVACON is seeking a dynamic and experienced Pharmaceutical Project Manager to lead key initiatives in cell and gene therapy pharmaceutical projects for a 3+ month assignment in the Baltimore-Washington, DC area. This role will oversee the complete lifecycle of advanced pharmaceutical projects in a fast-paced, cutting-edge environment. The successful candidate will have a strong background in project management within the pharmaceutical industry, exceptional organizational skills, and the ability to work collaboratively with cross-functional teams.
Responsibilities and Duties:
Work Arrangement: Primarily onsite, with limited flexibility for remote work.
Responsibilities and Duties:
- Lead and manage cell and gene therapy pharmaceutical projects from conception to delivery, ensuring all project milestones are completed on time, within budget, and according to client expectations.
- Create comprehensive and agile project plans, outlining key milestones, deadlines, resource allocation, and risk mitigation strategies to drive successful project outcomes.
- Facilitate seamless coordination with internal cross-functional teams and external stakeholders, ensuring alignment and tracking progress while swiftly addressing project deviations.
- Proactively identify, assess, and mitigate potential project risks, ensuring effective solutions are in place to handle issues before they affect timelines or quality.
- Use industry-leading tools and techniques to monitor project performance, ensuring compliance with regulatory requirements and adherence to pharmaceutical industry standards.
- Deliver insightful project updates to senior management and stakeholders through clear, concise, and data-driven reports and presentations.
- Ensure meticulous oversight of project documentation, including protocols, reports, and regulatory submissions, while maintaining compliance with industry regulations and quality standards.
- Ensure all project activities adhere to the latest regulatory standards and best practices in cell and gene therapy development.
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field is required; an advanced degree (e.g., MS, PhD, or MBA) is strongly preferred.
- Minimum of 7-10 years of project management experience in the pharmaceutical industry, preferably in cell and gene therapy or biologics development.
- PMP or equivalent project management certification (e.g., PRINCE2, CAPM) is highly desirable.
- Proven track record of successfully managing complex pharmaceutical projects in a highly regulated environment.
- Strong understanding of drug development processes, regulatory requirements, and quality standards.
- Proficiency in TrackWise or similar Quality Management Systems is highly preferred.
- Excellent organizational, leadership, and communication skills with proficiency in project management software and tools.
- Leadership: Proven ability to inspire and lead cross-functional teams, driving successful outcomes in a fast-paced, regulated environment.
- Critical Thinking & Problem-Solving: Demonstrated expertise in identifying root causes, developing creative solutions, and implementing corrective actions effectively.
- Communication: Strong verbal and written communication skills, with the ability to effectively convey project status, risks, and requirements to stakeholders at all levels.
- Time Management: Efficient in managing multiple projects and tasks simultaneously, ensuring project timelines are consistently met.
- Attention to Detail: Meticulous in ensuring all project aspects comply with quality and regulatory standards.
- This role involves working in both corporate office and pharmaceutical manufacturing/laboratory settings, with flexibility for occasional site visits to ensure project objectives are met.
- Occasional internal and external meetings, along with on-site reviews and client facility visits, may be required.
- Reports directly to the Associate Director of Quality Assurance, with opportunities to collaborate across departments.
- May supervise junior project managers, coordinators, or staff.
Work Arrangement: Primarily onsite, with limited flexibility for remote work.
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