Senior Scientist, Method Development/Technology Transfer AS&T job in Morris Plains
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
In this role, the Senior Scientist, AS&T will support method development and compliance activities within the Quality department as well as support ongoing international process transfer and stewardship.
• Executes and supports transfer of analytical methods between TRD-QC, to other Novartis sites, and to 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.
• Helps maintain progress of projects
• Identifies needs for training courses and development of new skills.
• Supports recruiting activities by participating in interviews and provides candidate assessment in addition to basic activities.
Analytical Development and Optimization
• Optimizes analytical methods as the needs arise or to replace existing ones.
• Supports creation of validation plan and technical reports
• Coordinates validation activities
• Ensures that all planned, executed and documented activities are aligned with the company, site and MT objectives.
• 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
• Performs or supports other tasks related to MS&T and site operations, as needed
• Ability to travel internationallycation: BA or MS in biology, chemistry, biochemistry, microbiology or other related science.
Experience: • Minimum 5 years of experience in Bio-Analytical method development, Quality Control or a technical support function.
• Demonstrated knowledge and skills in multiple bioanalytical techniques/equipment
• 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 LIMS systems.
• 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.