Associate Director, Manufacturing - Upstream

Location
Durham, NC
Posted
Sep 29, 2021
Ref
2021-6322
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 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 Associate Director, Manufacturing, is responsible for organizing, managing, and continuously improving the manufacturing operations and process at the assigned manufacturing site.  

Responsibilities

  • Leads teams who make up either upstream or downstream manufacturing, whose direct responsibilities include producing product on the manufacturing floor.
  • Provides guidance and oversite to the process and production, ensuring material is made in a safe and compliant manner and meeting company targets.
  • Develops staff, to accommodate needs as a growing organization.
  • Produces clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations.
  • Ensures scheduled operations for manufacturing meet monthly targets. Ensure manpower resources are adequate to complete operations.
  • Leads critical level investigations as related to the manufacturing process. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
  • Ensures batch related documentation (batch records and SOPs) is closed in a timely manner to support batch release.
  • Maintains robust training program to ensure timely, efficient, and effective training of individuals.
  • Participates in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
  • Develops and provide monthly manufacturing metrics.
  • Identifies and implements continuous improvement opportunities for process and production related items.
  • Initiates various personnel actions to include recruiting, onboarding, performance management, training, promotions, transfers, etc.
  • Other related duties as assigned.

Qualifications

  • B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • 10 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture and recovery.
  • Solid knowledge of FDA regulations and GMP systems.
  • Demonstrated technical knowledge of bioreactors, disposable technology, chromatography, TFF, and aseptic processing a must.
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
  • 5 years in a management role, with increasing responsibility.
  • Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
  • Experience with viral manufacturing, and transfection a plus.

 

 

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.

 

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