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

Location: Morris Plains, NJ

Shift: Monday - Friday AM Shift (8:00am - 4:30pm)

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 interpers