Full-Time Project Manager, New Product Development

We are seeking a dynamic and experienced R&D Project Manager to lead and oversee multiple new product development projects within the pharmaceutical, biotechnology and AgBio sectors. The ideal candidate, will be responsible for planning, executing, and finalizing projects, to a high Quality driven standard and according to strict deadlines and within budget. They will interact closely with R&D, quality, commercial, and manufacturing team members to ensure the successful completion of the design control process for new products. This role requires a strategic thinker with strong leadership skills, technical expertise, and the ability to manage cross-functional and multi-geographical teams.

Key Responsibilities:

• Project Planning and Management:
  • Define project scope, goals, and deliverables in collaboration with senior management and stakeholders.
  • Develop comprehensive project plans, including timelines, resource allocation, and budget management in partnership with the R&D, Commercial, Ops, Manufacturing, QA/RA. 
  • Support and implement New Product Design and Development Plans in accordance with the design control requirements of: 21 CFR 820, ISO 13485, and all applicable design control procedures.
  • Monitor and track project progress, ensuring timely and within-budget delivery.
  • Identify potential risks and implement mitigation strategies.
• Team Leadership:
  • Lead and manage cross-functional project teams, fostering a collaborative and high-performance culture.
  • Assign tasks and responsibilities to team members and provide guidance and support.
  • Facilitate communication and collaboration among team members and stakeholders.
• Technical Oversight:
  • Oversee the technical aspects of projects, ensuring adherence to industry standards and best practices.
  • Evaluate and integrate new technologies and methodologies to enhance project outcomes.
  • Conduct regular project reviews and provide technical input to address challenges and optimize solutions.
• Stakeholder Management:
  • Act as the primary point of contact for all project-related communications with stakeholders.
  • Prepare and deliver project reports, presentations, and documentation to stakeholders and senior management.
  • Ensure stakeholder expectations are managed and met throughout the project lifecycle.
• Quality Assurance:
  • Implement and maintain quality control processes to ensure the highest standards of project deliverables.
  • Conduct post-project evaluations to identify areas for improvement and best practices.

Key Behaviors:

• High Pressure Situations:
  • Ability to work in high-pressure situations and fast-paced environments.
  • Adaptable to shifting priorities with a can-do attitude.
  • Collaborative engagement across functions to achieve project goals.
• Communication:
  • Proficient in using various tools to communicate complex ideas and problems in an accessible manner.
  • Effective communication skills at all levels within and external to project teams.
• Initiative:
  • Self-starting with a proactive approach to project management.

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• Education and Experience:
  • Bachelor’s degree in an Engineering or Scientific discipline.
  • Minimum of 2-3 years’ experience in project management and new product development, ideally within the pharmaceutical, biotechnology, or AgBio sectors.
  • Minimum of 3-5 years proven experience working within large, global, multi-discipline R&D or product development projects that include both business and technical resources within the pharmaceutical, life sciences, or diagnostics arena.
• Technical Skills:
  • Strong understanding of R&D processes, methodologies, and technologies.
  • Product development experience and knowledge of product development frameworks and procedures, specifically systems-level experience designing and supporting multiple disciplines in a scientific field.
  • Demonstrable knowledge of Quality Management Systems and experience ensuring compliance to ISO and Regulatory requirements.
  • Experience with medical devices FDA QSR and ISO13485, reagent manufacturing, international project management skills, validation/qualification process, and knowledge management.
• Certifications:
  • A recognized project management qualification (e.g., PRINCE, PMI PMP).

Computer Skills:

• Project Management:
  • Proficiency in Microsoft Project, Smartsheet, and ERP systems (e.g., IFS, SAP).
• General:
  • Proficient in Microsoft Office, Outlook, Word, Excel, SharePoint, and web browsers.

Leadership and Interpersonal Skills:

• Excellent leadership and team management abilities.
• Strong analytical and problem-solving skills.
• Exceptional communication and presentation skills.
• Ability to motivate and inspire teams to achieve project goals.

Additional Qualifications:

• Experience managing projects from initial inception through to delivery and benefits realization, including cost/schedule performance, risk management, and metrics reporting.
• Ability to work effectively under pressure and meet tight deadlines.