Pharmaceutical Project Manager – Oral Solid Dose Manufacturing

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This is a temporary contracted position for approx. 6 months. On-Site with some flexibility for hybrid.

MEDVACON is seeking a dynamic and experienced Pharmaceutical Project Manager to lead key initiatives related to oral solid dose manufacturing of pharmaceutical products for a 6 month assignment in the Middlesex- Somerset, NJ 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, CMO and CDMO industry, exceptional organizational skills, and the ability to work collaboratively with cross-functional teams.
Responsibilities and Duties:

• Lead and manage oral solid dose 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 current 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 pharmaceutical oral solid dose manufacturing.

Qualifications:

• 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 oral solid dose manufacturing in CMO and/ or CDMO facilities.
• 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 MasterControl, TrackWise and similar Electronic Quality Management Systems is highly preferred.
• Excellent organizational, leadership, and communication skills with proficiency in project management software and tools.

Skills and Competencies:

• 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.

Work Environment:

• This role involves working in both corporate office and onsite pharmaceutical manufacturing/ laboratory settings, with flexibility for occasional site visits to ensure project objectives are met.
• Regular internal and external meetings, along with on-site reviews and client facility visits, may be required.

Reporting Structure:

• Reports directly to the Head of IT, Engineering and Quality Assurance, with opportunities to collaborate across departments.
• May supervise junior project managers, coordinators, or staff.

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