Job Title: Development Manager Location: San Diego, CA
Department: Assay Development R&D Reports to: Senior Manager or Director
FLSA Classification: Exempt
Prominex Inc. is a startup molecular diagnostic company with an experienced team of passionate and energetic scientists driven to create fast and affordable molecular diagnostic solutions across the globe. We are focused on infectious disease assays in point-of-care and home-based settings. We are looking for an enthusiastic and dedicated Development Manager to design, implement, and execute analytical and scientific experiments to drive Product Development. Demonstrates high degree of organization and planning and the ability to apply scientific principles to plan out and execute Validation and Verification experiments. Able to lead a group of research associates to guide them through the Product Development Process. This individual demonstrates technical proficiency, high degree of organization and planning and the ability to apply and train scientific principles.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Defines tasks and plans work required to meet Development, Research and Contract Manufacturer needs
- Ensures data, protocols and reports meet analytical requirements
- Maintains project documentations in accordance with internal and external requirements.
- Writes and revises technical reports, protocols and Work Instructions/SOPs
- Keeps accurate records of work undertaken
- Uses computer software to analyze data and to produce diagrammatic representation of results
- Runs a Product Development Group
- Shares results product development with colleagues through presentations or discussions at team meetings
- May need to train or assist in the transfer of analytical and quality control methods with Contract Manufacturer
QUALIFICATIONS AND TECHNICAL SKILLS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience in Product Development of IVD clinical diagnostic products
- Solid knowledge of molecular biology, biochemistry or related disciplines
- Experience in lateral flow chemistry is a plus
- Good understanding of nucleic acid amplification and related techniques
- Understanding of Scientific Method, experimental design, and statistical analysis
- Ability to analyze data and come to valid scientific conclusions
- Ability to present data to medium and large groups both internally and externally
- Sound technical writing skills. Publications are a plus.
- Ability to work in and/or lead small teams
- Projects require substantial knowledge of state-of-the-art principles and theories in area of expertise
- Uses professional concepts and procedures to establish and scale up analytical and purification methods
- Provides scientific guidance and training to less experienced staff
- May directly supervise one or more members of a core group
EDUCATION AND EXPERIENCE:
- BS and 12+ years related experience OR
- MS and 6 years OR
- PhD and 2-5 years related experience in a scientific discipline or equivalent in engineering.