• Produces clinical and commercial material on an annual basis that meets the site strategic objects and is compliant with cGMPs and safety regulations.
• Point person on shift to assign/distribute the work and coordinate emergency situations.
• 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.
• Ensures accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
• Demonstrates an appropriate level of understanding of the operations performed in the production unit.
• Identifies and implements continuous improvement opportunities.
• Summarizes shift progress via email at the end of the shift.
• Exhibits safety leadership by example (e.g., utilize proper PPE when performing job functions).
• Leads and mentors staff.
• Writes performance reviews and annual goals, holds one-on-ones, and handles HR related matters.
• Other related duties as assigned.

• Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 5 years of 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 degree.
• Solid knowledge of FDA regulations and GMP systems.
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
• Experience with viral manufacturing and transfection a plus.
• Previous supervisory experience and demonstrated ability to lead a team preferred.
• Must be able to lift over 35lbs.
• Approximately 10% travel.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Additionally, Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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