Scientist, AS&T

Band

Level 3

 

Job Description Summary

In this role, the Scientist, AS&T will support method development/transfer, analytical testing, training QC personnel and tasks related to compliance activities within the Quality department.

 

Job Description

Major accountabilities:

Technology transfer

• Executes and supports transfer of analytical methods between TRD-QC, to other Novartis sites, and to and from CMOs.
• Performs evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.
• Supports the assessment of analytical equipment existing in third party laboratories to determine equivalence for those that different between Sending Unit (SU) and Receiving Unit (RU).
• Executes training plan and transfer protocol for methods to be transferred in an out of MP.  Author transfer report for analytical methods and follow up with RU post transfer.
• Schedules and executes method transfer activities and co-validation of methods if required with Receiving or Sending Unit using Novartis procedures and guidelines from other platforms such as ICH, FDA, EP, USP and JP guidance if available.
• Identifies gaps relevant to procedures required for analytical transfer within Novartis and out of Novartis.
• Responsible to coordinate other transfer activities regarding to supplies to RU and logistics.

Analytical Development and Optimization

• Support senior team members to optimizes analytical methods as the needs arise or to replace existing ones.
• Supports creation of validation plan and technical reports

Compliance

• Lead and perform OOS/OOE/OOT investigations and deviations supporting Bioanalytics department operations
• Perform Change Control activities such as initiation, change phase management, and impact assessments supporting groups outside the Bioanalytics department.
• Support with activities related to QC systems such as LIMS, ELN, etc.
• Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.

​Support of Quality Control and other partners

• Assists QC and Quality Assurance in investigations of assay-related issues and recommends solutions.
• Provides timely response to requests for support of manufacturing deviations, investigations and change requests.
• Provides technical training to key QC and other personnel as required.
• Evaluates new methods, equipment and technologies.
• Provides analytical support to internal MS&T and other partners as needed
• Build libraries of atypical data along with the results of their investigation findings.

Support of regulatory submissions and audits

• Assists in preparation to internal and external GMP and HSE audits, including, but not limited to International, Federal (FDA, DEA, EPA, OSHA), State and local regulations as applicable. 
• Prepares data, performs the data integrity auditing and contributes to regulatory submission documents

Other

• Performs or supports other tasks related to MS&T and site operations, as needed
• Support with all laboratory testing such as FUT assay, stability testing, MOI testing, etc. under the responsibility of AS&T.

Key performance indicators:

• Timely delivery on commitments and departmental KPIs
• Timely responses and solutions to analytical issues
• Efficient and flexible usage of the available resources
• Compliance to all relevant company policies and guidelines
• Exhibiting core Novartis values and behaviors, and fostering these within the team

Minimum Requirements:

Education:

BA or MS in biology, chemistry, biochemistry, microbiology or other related science.
 

Work Experience:

• Experience in Bio-Analytical method development, Quality Control or a technical support function.
•  Minimum: 5 years of experience.
• Demonstrated knowledge and skills in multiple analytical techniques
• Expertise in ICH and FDA/EMEA GMP requirements
• Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines
• Ability to manage projects and lead teams utilizing modern project management methodology and tools.
• Knowledge of statistical tools and methods
• Strong verbal and written technical communication skills
• Strong interpersonal skill
• Proficiency using MS Word, Excel, and MS project
• Knowledge of cGMP, USP and FDA guidelines.
• Knowledge of QC systems such as ELN, LIMS, SAP, etc.
• Knowledge of Change Control systems, such as Agile PLM
• Knowledge of Quality Management Systems, such as Trackwise
• 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.

Skills:

Internal orientation

• Thorough understanding of cGMP requirements
• Good communication and organisational skills
• Ensure customer satisfaction and react to customer requests
• Is seen as a competent team player
• Independent
• Results-driven and goal-oriented work ethic

Others

• Strong ability to work independently and compliantly
• Strong analysis and decision-making skills surrounding documentation
• Pays attention to detail
• Able to proof work and identify non-standard format or wording, and errors within documents

Languages:

• English.

The pay range for this position at commencement of employment is expected to be between $89,600 and $166,400/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.

 

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

$89,600.00 - $166,400.00

 

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