Manager, Manufacturing Technical Support

Location
Durham, NC
Posted
Jul 07, 2022
Ref
2022-6636
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 Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

The Manager, Manufacturing Technical Support, provides technical leadership and guidance to the Manufacturing team by ensuring that continuous improvement projects are identified and implemented and that new changes/projects are assessed taking into consideration operating model and impact to cGMPs, SOPs and applicable guidelines and normative.

 

Please note: Two positions are available - one will focus on Cell Expansion/Upstream and one will focus on Downstream/Drug Product.

Responsibilities

• Leads manufacturing technical support specialists to support manufacturing, and interface with support groups to implement changes and continuous improvement processes.
• Leads a team that supports MES MBR execution on the shopfloor and drives changes to gain efficiency.
• Oversees and coordinates all manufacturing related deviations.
• Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input for analysis and driving process technology innovations.
• Authors manufacturing investigations and meets all targets for timely closure and CAPA completion.
• Works with the Manufacturing team to prioritize/coordinate of eMBR updates.
• Oversees technical training program within the Manufacturing team to ensure operators are qualified, and End to End training is performed.
• Oversees and coordinates change control for process and product-related changes.
• Ensures technical support to the Manufacturing team is provided and act as a technical SPOC to facilitate and collaborate with other groups department to ensure technical solutions are identified.
• Works with the Manufacturing team to create specific process monitoring and control plans to sustain performance against targets.
• Drives continuous improvement in all LEAN innovation, Quality, Productivity (LEAN) production and other processes/procedures to enable process unit performance to remain competitive and compliant.
• Supports implementation of Value Stream organization and ensure sustain by promoting empowerment and accountability.
• Fosters and supports a team culture that is engaged and empowered.
• Translates organizational objectives into a strategic plan to enable the Manufacturing team to plan future activities to deliver all targets.
• Coordinate with Quality to ensure compliance and continuous improvement in the manufacturing process.
• Role models in accordance with Novartis Values & Behaviors.
• Ensures CAPA and Deviations are closed on time and according to throughput time target.
• Economic management of costs and investments (e.g. by efficient planning and utilization of technical and human resources).
• Contribute to Site Manufacturing financial /business goals.
• Maximize Quality and process improvements.
• Minimize rejected patient lots and write-offs.
• Other related duties as assigned.

Qualifications

• Bachelor's Degree in Biotechnology, Biopharmaceutical, Pharmaceutical Technology, Chemistry, Microbiology, Pharmacy or other Life Science-related scientific degree with 7 years' experience in a biopharmaceutical, pharmaceutical or chemical manufacturing environment.
• Knowledge of a process-oriented organization and a self-directed culture a plus.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus.

 

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. 

 

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!

 

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.

 

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. 

 

Vaccine Policy:

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.

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