Specialist - MS&T

Job Description Summary

The purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process and Validation activities, executes preparation and updating of Risk assessments and documentation for Validation activities.

Job Description

Major accountabilities:

Chemical, Biochemical and/or Biotechnological Expertise

• Good understanding of physico chemical properties of chemicals and buffers (e.g. buffer capacity, stability), including basic analytical methods (e.g. pH, conductivity, density)
• Good understanding of biotechnological processes (e.g. fermentation, cell cultivation techniques), purification techniques (e.g. filtration, chromatography).
• Basic understanding of biochemical processes
• Experiences in preparation of Nitrosamine, Raw material risk assessments and declarations for residual solvents and Elemental Impurities.

Validation Expertise

• Create validation documentation including process validation protocol/reports, risk assessment, ongoing process verification (OPV) plans/ reports, cleaning validation protocol/reports based on alignment with Site Validation Lead.
• Preparation of Transport Validation/Verification Protocols and conduct the necessary studies in coordination with cross functional teams. Collect the results and create the reports. Ensure all collected data is accurate and comprehensive and that protocols comply with regulatory requirements and organizational standards.
• Support in prepration and updation of Hazard Analysis Critical Control Point (HACCP), Control strategies and FMEA risk assessments.
• Ensure the timely availability of technical documentation as per Novartis guidelines.
• Perform OPV/CPV evaluations, assess process performance and provide insight, recommendation and conclusion to the site MS&T team.
• Create and update process excursion signals (PES)
• Review key documents and coordinate input for relevant registration documents to ensure accuracy and completeness.
• Ensure all site validation activities comply with Novartis requirements and GMP, managing any deviations related to these activities, including oversight of pre validation and validation resulting from technical changes.
• Possess a fundamental understanding of pharmaceutical analytical testing.
• Ensure project tracking documentation/tools are updated according to plan.
• Collaborate closely with the development organization (or sending site) for technical transfers and new product launches to ensure knowledge transfer, appropriate control strategies, risk analysis and control, and readiness for commercial process validation
• Coordinates prerequisites for PPQ batches (Qualification status, Status of the analytical methods, raw materials, consumables), updates Risk Assessments for Microbial buffer hold validation, and generates deviation lists for PPQ batches
• Preparation, approval and life cycle management of Gxp documents
• Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting.
• Coordinates documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable.

Manufacturing Excellence

• Desired to be familiar with Manufacturing Process Transfer.
• Contribute to process improvement and optimization for product transfers.

Training

• Own the Training Curriculum for Own Job Profile

Ideal Background / Requirements for the role

• Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
• Min 5 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance in Large Molecules platform/facility
• Should be familiar with regulatory guidance on validation, product filing and post approval changes.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
• Expertise in reviewing and writing technical reports
• Good communication, Presentation and Interpersonal skills
   

Key Performance indicators:

• Quality / Accuracy / Right First Time
• Timeliness
• Deviations / Escalations

Skills:

• Effective communicator.
• Conflict management.
• Change Control.
• Continual Improvement Process.
• Efficiency.
• Employment Discrimination.
• Flexibility.
• General HSE Knowledge.
• Good Documentation Practice.
• Knowledge Of CAPA.
• Knowledge Of GMP (Good Manufacturing Practices).
• Lean Manufacturing.
• Manufacturing (Production).
• Manufacturing Process.
• Process Control.
• Production Line.
• Productivity.
• Risk Management.
• Root Cause Analysis (RCA).
• Well-Being.

Languages :

• English.

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)

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