Major accountabilities:

Stewardship:

• Maintain the process control strategy. Monitor all critical variables and key variables using statistical analysis and conducting regular product specific data trending. Review Annual Product Quality Review (APQR) to ensure products and processes are in a state of control.  
• Create and maintain product Quality Risk Analysis (QRA). Assist in initiating the product monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory.
• Maintain oversight and knowledge of the entire manufacturing process performed on site and throughout the entire commercial lifecycle, acting as the Single Point of Contact (SPOC)
• Track and evaluate product performance, detect issues, implement Corrective and Preventive Actions (CAPAs), and lead or support root cause investigations of process failures.
• Present product performance and status of product improvement projects in site Manufacturing Robustness Review Board (MRRB).
• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
• Ensure creation of Master Batch Record and own change control. Support registration activities as needed.

Validation:

• Ensure the continued state of validation (process, cleaning, ongoing verification etc.). Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV).
• Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.
• Support site validation planning by reviewing and approving validation protocol and report related to technical changes for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).

Launch & Transfer:

• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready
• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
• Provide the necessary data for technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and support at the receiving site as needed.

Manufacturing Excellence:

• Design and manage optimization projects, provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability
• Collaborate with Operational Excellence (OPEX) for product and process improvements

The salary for this position is expected to range between $108,500 and $201,500 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Minimum Requirements:

• BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology and 5 years of experience in process support, manufacturing, manufacturing science and technology, technical development or quality.
• Proven process understanding - thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
• Expert in reviewing and writing technical reports.
• Sound experience of data handling and applied statistics is a must.

#LI-Onsite