Head of MS&T, Carlsbad (Associate Director) - Novartis : Job Details

Head of MS&T, Carlsbad (Associate Director) – Novartis. Lead the site's MS&T organization to maintain and improve scientific oversight of manufacturing processes and technical changes, ensure product and technical stewardship, and drive quality and compliance across functions at the Carlsbad site.

• Ensure robust product stewardship for all products manufactured at the site, with end-to-end technical oversight of product manufacturing processes across the commercial lifecycle. Safeguard, maintain and develop the scientific information of product processes.
• Set objectives and develop vision for the department. Manage the MS&T career path, succession planning, training programs and career progression within the site. Drive a culture of quality and compliance across the MS&T team.
• Lead site activities related to technology transfer, change management and process improvement. Encourage identification and implementation of new and innovative technologies. Propose business cases as needed.
• Ensure oversight of technical changes and lead end-to-end change control management, working cross-functionally as required. Contribute to change records as impact assessor and action owner per Novartis requirements. Support deviation closure as a technical resource to ensure effective product impact assessment and root cause analysis. Own CAPAs as appropriate to ensure compliant and timely closure.
• Support manufacturing excellence by setting standards and developing technical capabilities. Identify and address process issues, maintain state of control, and ensure technical expertise for CAPEX projects.
• Lead execution and maintenance of the site Validation Master Plan activities including annual revalidations (aseptic processing, media fills, equipment requalification) and continuous improvement. Support C&Q activities related to site build and initial start-up.
• Interface with Health Authorities for technical issues. Review and release regulatory proposals or information required for regulatory filings.
• Collaborate with other Site MS&T teams and global networks to reapply standard work, practices and improvements locally and globally.
• Work with global MS&T, Technical Research and Development to ensure Technical Life Cycle Management projects are identified, prioritized and delivered with excellence.

• BSc degree in engineering, biology, chemistry, or related field or equivalent experience, plus 8+ years' experience in pharmaceutical MS&T roles with demonstrated quality, compliance and process-improvement impact.
• Direct experience in an aseptic manufacturing setting.
• Expert in reviewing and writing technical reports.
• Fundamental understanding of standard pharmaceutical analytical testing.

• Prior experience with radiopharmaceuticals is a plus.
• Additional experience such as pharmaceutical formulation, process development, or manufacturing technology is preferred.

The pay range at commencement of employment is expected to be between $132,300 and $245,700 per year. Salary ranges may adjust due to market factors during 2025. Final pay determinations depend on various factors including location, experience, knowledge, skills and abilities. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a full range of benefits (including 401(k) eligibility and paid time off). Details of participation will be provided with an offer. This is an at-will position and the company reserves the right to modify compensation periodically.

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EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.