Specialist / Associate Manager - MS&T

Collaborate with Site MS&T and multifunctional technical operations teams within the Large Molecules platform to ensure seamless communication and effective problem-solving. Maintain oversight of process and validation activities, including preparation and updates of risk assessments and documentation for validation, OPV/CPV, change control, and technology transfer. Drive compliance and operational excellence by supporting cross-functional initiatives and ensuring timely execution of all technical deliverables.

Major accountabilities:

Chemical, Biochemical and/or Biotechnological Expertise

• Biotechnological Processes: Strong understanding of fermentation and cell cultivation techniques.
• Purification Techniques: Skilled in filtration and chromatography methods.
• Biochemical Processes: Basic knowledge of biochemical principles.
• Risk Assessments: Experience in preparing Nitrosamine assessments, raw material risk evaluations, and declarations for residual solvents and elemental impurities.
• Physio-Chemical Properties: Good understanding of chemical and buffer properties (e.g., buffer capacity, stability).
• Analytical Methods: Familiar with basic techniques such as pH, conductivity, and density measurements.

Essential Requirements:

Technical Expertise

• Strong understanding of biotechnological processes (e.g., fermentation, cell cultivation techniques).
• Skilled in purification techniques (e.g., filtration, chromatography).
• Basic knowledge of biochemical processes.
• Experience in Nitrosamine preparation, raw material risk assessments, and declarations for residual solvents and elemental impurities.
• Good understanding of physio-chemical properties of chemicals and buffers (e.g., buffer capacity, stability).
• Familiar with basic analytical methods (e.g., pH, conductivity, density).

Manufacturing Excellence

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

Change Control

• Strong understanding of global and local change control processes; able to advise on strategy.
• Align cross-functional teams, including Regulatory, on change control plans and site impact.
• Prepare and present change request plans for endorsement at the Change Review Board (CRB).
• Open and manage change requests, assign impact assessments, and oversee lifecycle of CRs.
• Track and report implementation status with cross-functional teams.
• Maintain accurate documentation, version control, and compliance with cGMP and regulatory standards.

Training

• Contribute to process improvement and optimization for product transfers.
• Ideal Background / Requirements
• Education: Bachelor's in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent; MSc/MS preferred.
• Experience: Minimum 8 years in MS&T (process validation) or large molecule drug substance manufacturing.
• Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
• Proven project management experience in cross-functional, multi-site environments.
• Expertise in reviewing and writing technical reports.
• Strong communication, presentation, and interpersonal skills.
• Proficient in English (oral and written).
• Desirable Requirements:
• Quality / Accuracy / Right First Time
• Timeliness
• Deviations / Escalations

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Commitment to Diversity and Inclusion:

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Division

Operations

Business Unit

Production / Manufacturing

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is 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 recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.