Scientist -IV (Reagent Development)

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.

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

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