QC Senior Scientist

Band

Level 3

 

Job Description Summary

Coordinate and execute all activities to ensure the timely testing and release of all samples, collaborate with team in the design and execution of validation and other major projects. Provide employees with training and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques and proactively provides education technical knowledge and skills to less experienced scientists.

 

Job Description

Job Description

Number of positions open:1

Shifts Available:

Sun-Wed PM (2:30pm-1:00am) - 1 position open

Location: Morris Plains, NJ
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

Major Accountabilities 

• Support Bioanalytical laboratory by execution of in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, qPCR, cell count and viability, sterility, and endotoxin.
• Coordinate and act as liaison for other departments
• Execute and supervise peer review of analytical data and archiving in lab documentation systems.
• Support and manage tracking and trending systems, KPIs and Quality Metrics Drives execution of method qualification/development & optimization/transfer as governed by protocols. Draft under supervision protocols compliant with ICH and NVS expectations
• Perform analyses and determine appropriate actions with regards to lab investigations, deviations, CAPAs, change control and continuous improvement to ensure continued compliance with all cGMP requirements.
• Assists and supervises equipment and metrology teams in troubleshooting equipment issues
• Lead and develop best practices within the team including fostering Lean principles.
• Support internal and external audits of laboratory facility as a recognized SME.
• Mentor and coach staff members for ongoing growth and leadership
• Work on shifts covering daytime / evening and one or both weekend days.
• Performs other job duties as assigned.

Key Performance Indicators

• Self-directed with a high degree of professional integrity, highly organized and detail oriented with ability to work independently and within the team.
• Flawlessly delivers quality results on time to all customers, internal and external. Recognized specialist in any particular field of laboratory matters and is capable to confidently communicate technical information to regulatory inspectors.
• Escalate issues and potential solutions to laboratory management in a timely manner.
• Demonstrated critical reasoning, strategic thinking, problem solving, troubleshooting, influencing and decision-making skills.

Ideal Background 

Education:

BA or MS in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology or other related science. Advanced degree may be an advantage but not essential.

Languages:                        

Fluent in English

Experience:                        

• Minimum of 5 years experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.
• Thorough knowledge of cGxP expectations
• Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines.
• Thorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture)
• SME level knowledge of a particular area of bioanalytical testing
• Experience using LIMS systems
• Experienced in writing OOS/OOE/OOT and/or deviation investigations
• Knowledge of LIMS systems.
• Experience in supporting internal and/or external laboratory audits
• Advanced written and verbal communication skills
• Advanced experience in the use of computer-based systems and applications associated with bioanalytical testing

Competency Profile

Specific Professional Competencies:

• Recognized expert in execution of cGxP requirements
• Superior communication and organizational skills
• Impeccable ability to identify and communicate errors in analytical execution
• Ensure customer (internal and external) satisfaction and react to customer (internal and external) requests
• Is a recognized SME and team player
• Is able to work independently, compliantly and is results driven.
• Is able