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

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 to multitask and support junior staff members whilst conducting own work
• Detail Orientated/ Able to proof work and identify non-standard format or wording, and errors within documents
• Requires walking / standing for extended periods (up to 6 hours) throughout the work shift
• Requires dexterity for fine motor tasks such as pipetting and sterile manipulations in biosafety cabinets
• May use a computer and multiple software packages for greater than 4 hours a day.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

The pay range for this position at commencement of employment is expected to be between $85,400 and $158,600/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network

 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

 

Salary Range

$85,400.00 - $158,600.00

 

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management