Takara Bio USA, Inc.
Nov 01, 2022Full time
Position Summary/Objective: The Scientific Project Manager is responsible for facilitating the transition of products from Design and Development to Operations. This role will work closely with R&D leads, Operations managers, and the Marketing management teams to ensure phase gate objectives are met throughout the product launch cycle (PLC) and design specifications are transferred effectively to support successful product launches. This role must be a self-starter and quick learner who can provide immediate contributions. This role must excel at managing multiple projects and priorities and in communicating across multiple levels of the organization. The Scientific Project Manager is an on-site role located in San Jose, CA. Essential Functions: Attend project team meetings serving as a liaison between R&D, Marketing, and Operations to keep phase gate tasks and product transfer activities on track. Understand the applicable Takara technologies to participate in technical discussions to help identify barriers to manufacturability or limitations in test processes. Communicate and manage information flow to ensure alignment on critical information. Serve as a mediator to help reach a consensus between teams on inconclusive decisions. Process risk management activities and where possible, identify means or provide suggestions to reduce risk. Drive interactions and collaborations with other departments to ensure coordination of product launch activities and alignment on common goals. Provide guidance to teams with the development of robust verification and validation plans, manufacturing scale up, and cost-effective quality testing. Review and track PLC projects to ensure tasks are complete and ready for the next phase. Present status updates and data analysis or metrics on project progress in various forums to technical and non-technical audiences. As necessary, suggest improvements to processes such as product transfer, QC method validation, equipment and process qualification, and product lifecycle management. Assist in the creation, update, and maintenance of internal policies and procedures for the Quality Assurance department. Build and maintain relationships with relevant stakeholders across functions and levels. Ability to influence stakeholders with strong oral and written communication skills. This position does not have supervisory responsibilities. Education/Certification, Experience, and Competencies: Advanced degree in a scientific discipline with strong background in molecular and cell biology, biotechnology, or biochemistry. Minimum of 5 years’ experience in a biotech or pharma with relevant work experience in project and/or program management within cross functional teams. Hands-on experience with NGS and DNA/RNA molecular biology is preferred. Regulated product development experience is a plus (CLIA, FDA, IVD). Project Management specific training and/or certification desirable. Very strong analytical and problem-solving skills and attention to detail. Exceptional organizational skills. Strong interpersonal and communication skills. Physical Demands/Work Environment: The position may be required to handle hazardous materials (return shipments). Hazardous material handling and chemical hygiene training is expected and will be provided. AAP/EEO Statement: Takara Bio USA, Inc. does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Disclaimer: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.