Key Responsibilities:

• Oversee shift operations to ensure the safe, compliant, and efficient production of clinical and commercial materials, consistent with site strategic objectives
• Point person on shift to assign/distribute the work to personnel and support any immediate action items
• Leads investigations related to the manufacturing process. Author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
• Ensures documentation (batch records and SOPs) are accurate and updated as required.
• Demonstrates an appropriate level of understanding of the operations performed in the production unit.
• Identify and implement continuous improvement opportunities across production processes
• Summarize shift progress and communicate updates via end-of-shift emails
• Model safety leadership by consistently using proper PPE and promoting safe practices
• Leads and mentors staff, writes performance reviews and annual goals, regular one-on-ones, and handles HR related matters.
• Other related duties as assigned.

Essential Requirements:

• Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 5 years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment;

OR

• Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3 years of experience in the manufacture of Novartis Gene Therapies product;

OR

• Seven (7) years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of a degree.

AND

• Strong knowledge of FDA regulations and GMP systems.
• Excellent communication and technical writing skills
• Proven project management capabilities including planning, budgeting, and team coordination
• Ability to lift 35 lbs. unassisted.
• Previous supervisory experience with demonstrated team leadership preferred
• Experience with Drug Product Manufacturing and Purification processes is preferred.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $81,200 and $150,800 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.

Company will not sponsor visas for this position.