Work as Scientist/Senior Scientists Bioanalytics at Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Scientist or Senior Scientists Bioanalytics

Job Description
PURPOSRE
Under minimal direction, direct and assist in functions supporting Bioanalytics.

RESPONSIBILITIES
• Perform BioAnalytical testing such as Flow Cytometry, ELISA, cell count, cell viability, residual bead assessment, qPCR, Potency.

• Perform all testing and activities compliantly following appropriate SOPs and procedures.

• Maintain controls and reference standards to support testing.

• Work on shifts covering daytime / evening and one or both weekend days.

• Review/approve data generated by other team members.

• Train others.

• Execute method qualification/optimization of methods.

• Participate in OOS/OOE investigation.

• Participate in deviation investigation/CAPA implementation in a timely manner.

• Support 5S and Lean projects.

• Continually identify areas for improvements in project work.

• Interface with regulatory agencies during audits.

• Knowledge of LabWare LIMS and/or other QC data systems.

• Knowledge of appropriate GMP/GLP quality systems (eSOPs, TEDI, etc).

• Support tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality and efficiency.

• Review Bioanalytics documents to ensure completeness, accuracy, consistency and clarity.

• Revise SOPs, forms, laboratory data sheets (LDS).

• Generate Cell Lines

• Monthly review of laboratory logbooks and monthly laboratory cleaning..

Candidate Profile
BS or MS in biology, biochemistry, cell biology, microbiology or other related science. Advanced degree in a scientific or relevant discipline is preferred. 5 years of direct experience in same equipment/processes is required for Scientist 8 years of direct experience in same equipment/processes is required for Senior Scientist. Candidate must have demonstrated technical leadership skills.

• Knowledge of cGMP and GLP

• Thorough knowledge of bioassay test methods, as appropriate.

• Knowledge of LIMS systems.

• Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.

• Detail-oriented with expertise in problem solving and solid decision making abilities.

• Strong written and verbal communication skills are essential.

Additional Information:
Experience: 8 years
Location: Morris Plains
Education: BS or MS in biology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality