We have been engaged to find an Assay Development Manager with experience leading In Vitro Diagnostics (IVDs). You will oversee scientific team members to support the development and manufacture of tissue based diagnostic assays and all associated reagents and stains in a regulated industry for use in medical devices.
You will be responsible for the planning, execution and development of molecular assay development projects, technology transfer to operations and, troubleshooting of problems in development and manufacturing, and the implementation adaptions of new technologies.
Exciting new opportunity with a world leader and innovator of tissue-based diagnostics solutions. Who Do You Know?
Assay Development Manager overview:
- Initiates, directs and executes scientific efforts in the areas of tissue-based assay development
- Collaborates with key stakeholders to insure efficient delivery (on time and within budget) of molecular product development milestones, on market support activities and development investigations
- Establishes and maintains program milestones and timelines
- Makes major contributions to all areas that need molecular expertise, including feasibility, development, assay transfer and manufacturing
- Leads the scientific team in staff training, maintenance and upkeep of laboratories and capital equipment, health and safety issues, implementation of compliance at Roche
- Provides open environment and promotes teamwork during the development process
- Assist in hiring process, preparation of departmental budgets; assists in monitors department spending
- Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations
Assay Development Manager qualifications include:
- MS or PhD in molecular biology, biochemistry, or a related discipline
- 3+ years relevant scientific and development experience, including extensive experience in molecular assay development
- 2+ years of direct management experience in an industrial setting.
- Demonstrated record of accomplishments (e.g., product development and support) within an FDA / IVDR regulated environment.
- Knowledge in developing, implementing, and supporting new molecular product development and diagnostics
- Maintains broad knowledge of state-of-the-art principles and theories in chemistry, biochemistry, and molecular biology
- Strong verbal, written communication skills. Ability to prepare and present information to groups.
- Ability to lead and motivate others in both matrixed and direct-line management environments
- Experience with SAFe Agile methodologies would be a plus
Industry: IVD, Assay, Molecular Biology, Diagnostics, Oncology
Job Code: j-232
Location: Tucson, AZ