Job Description
Qualifications
Job Summary:
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 510Ks, 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.
Additional Information
Kindly Regards,
Warm Regards,
Sneha Shrivastava
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Tel: (732) 549 5307x 209 (extn)
Fax: (732) 549 5549
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70