Scientist -IV (Reagent Development

Scientist
-IV (Reagent Development)

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas:
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

The Senior Scientist position, Reagent Development, will be working as part of a multi-disciplinary team, responsible for a compliant development of a new diagnostic medical device encompassing assay development and integration with the instrument. He/she will collaborate on refining assay requirements, scale up of reagent production and verification and validation activities.

• The candidate will be independently responsible for optimizing instrument related solution preparation, developing commercial –ready process based upon R&D processes, scaling up reagent production, validating assay reagent production and transferring production processes.
• The successful candidate will be responsible for designing and improving processes for reagent manufacturing, independently reviewing manufacturing procedures and execute experimental processes, as well as serving as technical representative in transferring new products.
• Additional responsibilities will be the design and execution of experimental procedures, and critically analyzing experimental data and interpret results.
• The incumbent will practice good laboratory practices (GLPs), safety requirements, laboratory Standard Operating Practices (SOPs), company policies and procedures.

Qualifications:

• A minimum of a Master's degree (PhD degree preferred) in Biology, Cell Biology, Molecular Biology, Biochemistry, Bio molecular Engineering or related field.
• At least 10 years of experience working in biological process development
• Experience working with the FDA on 510
  
  Ks, design control process and Good Manufacturing Practices for Medical Devices.
• Possess demonstrated structured problem solving skills

Desired skills:

• Must have a strong knowledge of statistics, especially related to Design of Experiments (DOE) and excellent technical writing skills.
• Experience with internal and external audit procedures.