Large Molecular Senior Lab Manager

• Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
• Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
• Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
• Responsible for lab planning, budgeting, goal setting and achievements.
• Maintain lab daily operation.
• Ensure the quality and timely of lab deliverable.
• Familiar with marking trend and develop new service items.
• Support business development activities to reach/exceed the company business goal.
• Perform the tasks assigned by line manager.
• Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization.
• As the member of test facility/site management.
• Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc.

• Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study.
• Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual.
• Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.
• Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented.
• Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented.
• Ensure documented approval of the study plan by the Study Director.
• Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel.
• Ensure the maintenance of a master schedule.
• Ensure that test facility supplies meet requirements appropriate to their use in a study.
• Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel.
• Ensure that test and reference items are appropriately characterized.
• Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures.
• If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.

• Provide input to line managers of their project team members' performance relative to project tasks.
• Support the project manager for the overall project planning and execution of the project timeline, budget, scope, and quality regarding the assigned projects. Ensure accurate and timely communication with customers regarding delivery of work product and project progress.
• Support the Project Manager in collaborating with project team members' line managers to facilitate issue resolution and optimize resource management.
• Participate in the internal and external communication for issue identification / resolution and customer satisfaction. And ensure to follow the company SOP or project-specific QC processes for the tasks coordination to solve the emerging issue/problem as necessary.
• Support the Project Manager to lead problem solving and resolution efforts to include management of risk, contingencies and issues. Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.

• Minimum of a Bachelor's degree or equivalent in a science or medically related field; an advanced degree is preferred.
• For Manager-level roles:
• At least 3 years of experience in a laboratory or CRO environment is preferred.
• For Director-level roles:
• At least 3 years of team management experience within a laboratory or CRO environment is preferred.

• Good problem-solving skills.
• Familiar with activity processes throughout a clinical trial with good knowledge in ICH- GCP, GLP, CAP and local regulations.
• Excellent customer management and problem resolving skills.
• To be proactive, flexible, organized, and aim to mitigate risk, understanding plans and outcomes fluctuate, and be highly communicative during the entire process.
• Good in maintaining good working relationships with sponsors and project team members.
• Strong communication and interpersonal skills, fluent communication of speaking and writing in English is preferred.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Strong software and computer skills, including MS Office applications.

• Strategic vs transactional mindset.

• Ability to gain insights and make proactive decisions quickly.

• Culture that fosters partnership and collaboration, where every voice is heard and valued.

• Ongoing support from senior stakeholders and leadership team.

Novotech