Senior Scientist - Nanoparticle Diagnostics
|, Maryland - United States
$90,000.00 - $140,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
This company is a proud subsidiary of an Australian Headquartered Biotechnology/Diagnostics leader, with a landmark project to build USA manufacturing capability - fully funded via a Department of Defence strategic investment.
They are a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for U.S. medical practitioners and consumers.
They achieve this by applying the working practices of our parent organisation through the integration of next-generation diagnostics, reader technology and software.
Their products are distinguished by their simplicity of use, rapid time to result and connectivity.
A world where people return to health as soon as possible.
Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.
To create rapid, accurate diagnostic tools that link people to optimal therapy.
The Senior Scientist – Nanoparticle, will be working as part of the multidisciplinary production team and is responsible for leading the development, analysis, validation and production of nanoparticles that will be used in company products. The role will also be accountable for co-ordinating external development and production activities with contract research groups and suppliers.
The Senior Scientist – Nanoparticle position will also involve the supervision and training of other scientists and technicians. The role will be responsible for promoting organisational products and technology within the scientific and medical community when required.
Duties and Responsibilities
- Develop and verify nanoparticles that will be integrated into reader technologies and diagnostic products. Ensure that the functionalised nanoparticles satisfy the product and assay requirement specifications.
- Assist in the preparation of product development plans and review verification testing plans.
- Characterise and analyse the biochemical and functional properties of nanoparticles produced for development activities and manufactured product.
- Perform and report on analytical testing of nanoparticles used for product development.
- Perform and complete forms for QC testing of particles used in the manufacture of product.
- Develop specifications and QC test instructions for nanoparticles produced in-house and supplied from third parties. Draft specification products, WIN and FRM for nanoparticles production and QC testing.
- Plan and execute experiments and activities for the characterisation, optimisation and validation of nanoparticles and assay components on time and to the required GMP and ISO13485 quality standards.
- Prepare progress reports and data files for key experiments and research or production activities.
- Present or publish data at internal and external meetings, write reports, and prepare documentation including methods and SOPs.
- Collaborate and contribute within multidisciplinary teams to provide innovative solutions to technical problems.
- Supervise scientists and/or technicians. Provide guidance with personal development plans and performance reviews of scientists and technicians under supervision.
- Assist in other non-research related activities in the business as required. This includes partaking in scheduled production activities when required, risk assessments and in marketing and human factor exercises.
- Bachelor’s degree in chemistry, biochemistry or related field with a broad bioanalytical background.
- Experience with Quality Management Systems.
Desirable (but not essential):
- A related postgraduate research degree such as a MS or PhD, with minimum of 3 years relevant industry experience.
EXPERIENCE & SKILLS
- Previous upscaling experience of manufacturing processes
- Proven record of developing nanoparticles and microparticles for different assay platforms.
- Work effectively within teams to meet objectives towards commercial deadlines.
- Self-motivated and be able to multi-task and manage complexity.
- Good motor skills and the ability to do fine and repetitive tasks.
- Excellent attention to detail and good organisational skills.
- Excellent oral and written communication skills.
- Strong interpersonal skills.
- Ability to identify defects in materials and processes.
- Competency in Microsoft applications including Word, Excel, and efficient use of email.
Desirable (but not essential):
- Experience in a leadership role
- Experience working in a GMP or ISO13485 environment.
University - Bachelor's Degree/3-4 Year Degree