• Produces clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs.
• Works on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment.
• Supports the product requirements to ensure that all products are produced according to plan.
• Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.
• Participates in information requests for FDA and internal audits of the manufacturing facilities.
• Maintains quality standards to meet cGMP requirements, CFR’s, and internal company policies directly related to the manufacturing process.
• Supports tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
• Looks for opportunities to implement operational excellence and continuous improvement.
• Partners with Quality to ensure a quality and compliant manufacturing environment.
• Assists the technical operations team to resolve any issues related to production.
• Other relates duties as assigned.

• Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 2 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 four (4) 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. OR Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 1 year experience in the manufacture of Novartis Gene Therapies product;
• Direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems.
• Strong technical writing ability.
• Proven ability to effectively lead and participate on teams.
• Ability to routinely lift over 35 lbs.
• Approximately 10% travel.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. The level of this position will be based on the final candidate’s qualifications.

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.