Cross-Functional PM for Regulated Product Development

TECAN CDMO SOLUTIONS PN SDN. BHD; Simpang Ampat; On-site; MYR 120,000 - 180,000; Full time

Job summary

TECAN CDMO Solutions PN Sdn. Bhd is seeking a capable Project Manager to lead and manage cross functional product development projects from planning through development, design transfer, industrialization and final release.

You will coordinate cross-functional teams, develop and maintain project plans, monitor KPIs and risks, manage stakeholders, ensure compliance with SOPs and regulations, and drive timely decision‑making to secure on‑time product launches.

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, or a related technical field.
• Minimum 4 years of project management or equivalent experience.
• PMP or equivalent project management certification would be a plus.
• Experience leading cross functional projects in a regulated product development environment.
• Fluent in English, both written and spoken.
• Strong presentation and communication skills with technical and non technical audiences.
• Automation, assay development and agile project management experience would be an added advantage.

Responsibilities

• Lead and coordinate cross-functional project teams across functions and locations.
• Develop and maintain project plans, schedules, resources, budgets, requirements, and milestones.
• Monitor project progress, KPIs, risks, issues, dependencies, and changes; implement mitigation actions.
• Drive timely decision-making and elevate critical risks and issues to the appropriate management boards.
• Manage project stakeholders and ensure clear, timely, and transparent communication.
• Coordinate project interfaces and dependencies with related projects.
• Ensure compliance with applicable development processes, SOPs, guidelines, quality systems, and regulations.
• Drive successful design transfer, industrialization, and final product release.
• Maintain accurate project documentation, reporting, forecasts, and business cases.
• Identify and resolve project conflicts and proactively manage project trade-offs.

Skills

Project management

Cross-functional leadership

Communication skills

Risk management

Education

Bachelor's or Master's degree in Engineering/Life Sciences/Biotech

Job description

TECAN CDMO Solutions PN Sdn. Bhd is seeking a capable Project Manager to lead and manage cross functional product development projects from planning through development, design transfer, industrialization and final release.

You will coordinate cross-functional teams, develop and maintain project plans, monitor KPIs and risks, manage stakeholders, ensure compliance with SOPs and regulations, and drive timely decision‑making to secure on‑time product launches.