Site MS&T Lead (Large Molecule)

Job Description Summary

Job Description

Key Responsibilities:

• Lead the Manufacturing Science and Technology organization and build a high-performing team of engineers and scientists
• Manage start-up activities for new site operations, including MS&T laboratory build and initial technology transfers
• Monitor and improve manufacturing processes, including preparation of data and reports supporting regulatory compliance
• Plan, execute, and document experiments, studies, and manufacturing processes qualifying equipment, materials, and processes
• Own and manage process, analytical, and characterization knowledge related to production and required raw materials
• Interface with global Manufacturing Science and Technology and change management organizations on process improvements and changes
• Serve as the scientific and technical representative for process-related topics with internal sites and external partners
• Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards
• Lead process and cleaning validation activities and continued process verification to maintain a state of control
• Perform process monitoring, data trending, and investigations to maintain product quality and prevent process drift

Essential Requirements:

• M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field, with at least 8 years of experience in biopharmaceutical manufacturing; or a B.S. degree with 10 years of experience in the same field
• Demonstrated leadership experience overseeing biopharmaceutical manufacturing operations within a cGMP environment, with accountability for technical decisionmaking, crossfunctional alignment, and sustained operational performance
• Current or previous experience supporting Large Molecule manufacturing processes within a biopharmaceutical production environment.
• Experience leading start-up activities and technology transfers for new manufacturing capabilities
• Hands-on experience supporting cell culture, recovery, purification, and or aseptic fill and finish operations
• Familiarity with global cGMP manufacturing regulations for drug substances, drug products, devices, and validation and qualification requirements
• Proven ability to communicate effectively and collaborate across Manufacturing, Quality, and Regulatory organizations
• Ability and willingness to travel up to 10% as needed

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $138,600 and $257,400 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.

To learn more about the culture, rewards and benefits we offer our people click here.

Relocation Support: Yes

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.

Accessibility and reasonable accommodations

The Novartis Group of Companies are 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 application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired