Environmental Conditions

Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

As the Functional Manager, Molecular Biology, you will lead a team of scientists and provide strategic and technical leadership in the development of molecular biology technologies, products, and applications. You will collaborate across functions to drive innovation, deliver high-quality solutions, address complex scientific challenges, and support the organization's mission of enabling customers to make the world healthier, cleaner, and safer.

Key Responsibilities

• Lead, mentor, and develop a team of scientists, including performance management, career development, and talent planning.
• Plan and prioritize team resources and workload to ensure effective execution of projects and alignment with business objectives.
• Provide technical leadership, coaching, and training to ensure scientific excellence and team effectiveness.
• Drive the development of molecular biology assays and technologies, from feasibility assessment through product development and commercialization.
• Apply technical expertise to solve complex product development challenges and support decision-making.
• Utilize statistical tools and Design of Experiments (DOE) to design studies, analyze data, and optimize processes.
• Author, review, and approve technical documentation, including protocols, reports, and design control records.
• Build strong stakeholder partnerships and communicate project progress, risks, and recommendations to senior leadership.
• Drive continuous improvement of products, processes, and laboratory practices. Ensure compliance with internal procedures, quality systems, and applicable standards (e.g., ISO 13485).
• Exercise independent judgment and decision-making authority within established policies and practices to drive project success, organizational objectives, and business outcomes.
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Requirements

• Advanced degree in Biological/Biomedical Sciences, Chemistry, Biochemistry, Biomedical Engineering, or a related field with at least 6 years of relevant industry experience; or Bachelor's degree with at least 8 years of relevant experience.
• Minimum 2 years of people management experience leading scientific or technical teams, and at least 3 years of hands-on laboratory experience in academic and/or industrial settings.
• Strong expertise in molecular biology assay development and optimization, including qPCR, dPCR, RT-PCR, NGS, and related nucleic acid technologies.
• Demonstrated success in leading, coaching, and developing scientists, with strong problem-solving and decision-making capabilities.

Proven ability to lead cross-functional initiatives and influence stakeholders across a

Key Responsibilities:

• Plan and execute global clinical trials with emphasis on North American operations, including site selection, initiation, monitoring, and close-out activities.
• Serve as the primary contact for North American sponsors, investigators, and regulatory stakeholders, ensuring alignment with global project objectives.
• Develop and implement comprehensive project management plans (including monitoring plans, risk management plans, and communication plans) tailored for North American operations.
• Manage cross-functional project teams and third-party vendors, providing guidance and support for North American project activities.
• Monitor project progress, quality, and compliance at North American sites, implementing corrective actions as needed.
• Conduct financial management and cost control for North American project components in accordance with contract requirements.
• Maintain professional communication in both English and Chinese as working languages for all project-related correspondence and collaboration.

Qualifications:

• Bachelor’s degree or above in Medicine, Pharmacy, Biology, or a related field.
• Minimum of 4 years of clinical trial project management experience, with at least 2 years focused on North American operations.
• Full professional proficiency in both English and Chinese (written and spoken) as working languages.
• Comprehensive knowledge of ICH-GCP, FDA regulations, and the North American clinical trial landscape.
• Experience in a CRO or sponsor environment with exposure to global clinical projects is preferred.
• Willingness to relocate to North America is highly preferred; long-term remote work arrangements will also be considered.
• Strong leadership, communication, and cross-cultural collaboration skills.
• Proficiency in Microsoft Office applications and clinical trial management systems.