Associate Director, Manufacturing Science and Technology (Downstream and Drug Product)

Location
Durham, NC
Posted
Jan 16, 2022
Ref
2022-6521
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

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 Therapy 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. Imagine the lives you could transform by joining the Novartis Gene Therapy team.

 

The Associate Director, Manufacturing Science and Technology is responsible for leading the Manufacturing Science and Technology organization at a manufacturing location to assure consistent and reliable production of clinical/commercial gene therapy drug substance, drug product, and packaged SKUs.  

Responsibilities

• Monitors and improves manufacturing processes, as well as the data and reports to support regulatory compliance of, gene therapy products.
• Defines and directs the activity of staff to plan, execute, and document experiments, studies, and manufacturing that qualify key equipment, raw materials, and processes for clinical and commercial production.
• Provides ownership and management for processes, analytical, and characterization knowledge related to the production of gene therapy products, and the raw materials need to make them.
• Builds and maintains a high performing staff of engineers and scientist to support ongoing production as well as process transfers into the site.
• Serves as a key scientific and technical representative for process-related issues at internal sites, as well as with external partners.
• Partners with Manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
• Partners with Regulatory to support submissions and approval of product applications.
• Performs trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
• Identifies and implements process improvements in conjunction with manufacturing operations.
• Reviews/provides feedback and technical/scientific support on project deliverables (e.g. remediation initiatives, plan reports).
• Leads investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective.
• Participates in the collection and interpretation of data and collaborate with other departments on all manufacturing related issues to drive issue resolution and support the organizational goals.
• Own the process, planning to avoid delays, and lead the activity to deliver a robust and effective product and manufacturing process.
• Other related duties as assigned.

Qualifications

• M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 8 years of experience in support of biopharmaceutical manufacturing or a B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and 10 years of experience in support of biopharmaceutical manufacturing.
• Excellent oral and written communication skills.
• Experience in senior laboratory and/or operational roles within a biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish.
• Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
• Strong technical knowledge of bio-manufacturing processes and regulatory requirements.
• Proven ability to effectively lead and participate on teams.
• May require up to 25% travel.

 

The level of this position will be based on the final candidate's qualifications. 

 

Why Novartis?

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.

 

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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