Supervisor, Manufacturing Downstream Drug Product, AM Shift

Job Description Summary

Job Description

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:

• Bachelors 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 $81200 and $150800 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 -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 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.

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 or call 1 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