Supervisor, Manufacturing - Drug Product (Days)
Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases. We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia. Imagine the lives you could transform by joining the Novartis Gene Therapy team.
The Supervisor, Manufacturing, is responsible for organizing, managing, and continuously improving the manufacturing operations and process at a manufacturing site.
Please note: This is a 12 hour rotating shift in a 24x7 Manufacturing facility.
- 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' 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 year 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.
The level of this position will be based on the final candidate's qualifications.
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Novartis Gene Therapies Benefit Summary:
Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.
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.
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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