The Thermo Fisher Scientific Quality Controls team is a group of passionate individuals dedicated to improving diagnostic medicine. This position is for a highly motivated Scientist to lead our R&D Molecular Controls custom services team. The R&D Molecular Controls customs team supports IVD developers by custom manufacturing quality controls and standards to assist in all stages of assay development, including feasibility materials, V&V, GMP in-kit controls, and assay roll-out verification materials. This position offers a unique opportunity to work directly with diverse customers worldwide and to truly enable diagnostic development at the cutting edge of technology and medicine.
The ideal candidate will be a strong team player who is passionate about assessing and anticipating customer needs. As Manager, this candidate will also enjoy developing and empowering employees and promoting a customer-focused culture, with an emphasis on product quality and rapid project turnaround time. This team functions in partnership with the controls sales team to work internationally with in vitro diagnostic device manufacturers and key opinion leaders at research institutions and clinical laboratories.
- Cross disciplinary responsibilities, including Scientist, Marketing, Business Development, and Manufacturing
- Custom quality controls and standards product development for qPCR, NGS, or other molecular technologies
- Manages a team of 4 to 6 scientists
- Manages rapid project evaluation and costing, project prioritization, and execution from feasibility to manufacturing to shipment
- Helps develop and communicate customs business strategy in collaboration with the commercial BD team
- Collaborates with molecular biologists, biochemists, bioinformatics, engineers, product managers, QA/RA, MFG, QC, customer support, other internal teams and external scientists
- Provides innovative ideas for new products and intellectual property
- Executes IVD development experiments, from proof of concept through to validation, submission and launch
- Represents the company at scientific meetings, gives talks and presents posters
- Some travel required to visit customers, collaborators, and attend conferences
- Masters Degree (or higher) in Molecular Biology / Genetics / Biochemistry / Organic Chemistry / Bioengineering and a minimum 4 years’ experience in the biotech industry.
- Must have excellent communication and presentation skills.
- Experience working directly with customers.
- Multidisciplinary background is highly desirable.
- Must be passionate about customer service and meeting customer needs.
- Values life-long learning.
- Has demonstrated abilities in rapid problem solving and outside-the-box thinking.
- Is extremely organized and driven to complete projects efficiently and quickly.
- Must be highly collaborative; Must have the ability to work within a diverse team.
- Must contribute to a supportive, positive work environment both within the team and in the greater community.
- Self-motivated, independent, and a proactive driving force of execution.
- Willingness to take on new challenges.
- Willingness to be flexible, creative, and adaptable in a complex, matrixed environment.
- Able to adapt to changing needs caused by time, budget, or other constraints.
Additional Preferred Experience:
- Experience in design control.
- Trained in ISO 13485, 21 CFR Part 820 Quality Systems Regulation, good manufacturing practices.
- Process improvement and/or six sigma.
- Statistical skills using current platforms eg. GMP.
- Has authored patents and/or papers.