Manufacturing Technical Support Lead (Associate Director)

Location
Durham, NC
Posted
Jun 07, 2022
Ref
2022-6637
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 Manufacturing Technical Support Lead, leads the Manufacturing Technical Support team in coordinating and planning of all activities with end-to-end manufacturing responsibility (manufacturing, clinical programs, deviation management, logistics, project work, operational excellence, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment and accountability). In addition, this role ensures full compliance with quality, Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), customer service, statutory, regulatory and Novartis requirements.

Responsibilities

Leadership and people management:

  • Role model of Novartis values.
  • Is a learner, not a knower.
  • Develops trusting and respectful relationships.
  • Manages your energy and impact.
  • Translates the strategic objectives of their team into detailed objectives and action plans.
  • Manages resource and task allocation within the team.
  • Arbitrates tasks prioritization.
  • Engages and motivates the team and delivers strong results with an empowered team.
  • Actively participates in the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining manufacturing unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit.
  • Supports the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates.
  • Ensures that associates are qualified for a GMP task prior to independent performance.
  • Monitors overall training compliance for in-scope associates.
  • Identifies and maintains a list of subject matter experts for in-scope areas of expertise.
  • Facilitates decision making in the team.
  • Leads, motivates and coaches support staff.
  • Transmits knowledge, skills and information to members of the team on objectives, problems, performance indicators, values and behavior.
  • Actively stimulates collaboration between the collaborators of the different PU / SU.
  • Builds and maintains a network with experts inside and outside the organization.

 Production support expertise:

  • Monitors compliance activities necessary for the release of batches produced in compliance with the defined dates.
  • Ensures that the processes remain consistent with good manufacturing practices (cGMP) and apply the rules and regulations for safety, health and the environment.
  • Provides a role of technical and scientific referent within their scope.
  • Ensures the appropriate management of the quality events within the appropriate timeframe (escalation, description, investigation of the cause, evaluation of the impact and criticality, etc.).
  • Ensures the definition of corrective and preventive actions (CAPA) within the appropriate timeframe to effectively resolve the problem, reduce its impact and prevent its recurrence.
  • Ensures the correct application of the change control processes.
  • Ensures the consistency of decisions, with the right ratio of effort to benefit, correlation with the criticality of the events to be managed.
  • Provides methodological and organizational support for major investigations or problems. Leads the task force in the event of a crisis.
  • Ensures, in their area of expertise, that the strategic objectives related to the performance of the production unit are achieved.
  • Evaluates capacity, resource requirements together with Process Team Lead.
  • Oversees and supports launch activities on the shop floor.
  • Supports S&OP process by supplying necessary data.
  • Ensures the implementation of the on-call schedule.

Batch Administration:

  • Manages the production documentation flow within the production unit (SOPs; MBRs; Forms...).
  • Oversees the production part of the Batch record review activities (Production review, Experts review).
  • Ensures that documentation is consistent with good manufacturing practices (cGMP). 

HSE and Quality: 

  • Guarantees the conformity of the manufacturing unit activities with regard to GMP and HSE rules, Novartis quality/safety policies, and the standards and quality/safety procedures.
  • Promotes and improves the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site.
  • Ensures overall inspection readiness for area of responsibility.
  • Guarantees the effectiveness of the Business Continuity Plan.
  • Implementation, compliance and governance of the practices explicitly defined in their role by the "Novartis Manufacturing Manual".
  • Part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management).
  • Drives the Lean culture to achieve Process Excellence, including the daily use of Lean Leadership, Visual Management, Tiered Accountability, Leaders Standard Work and Gemba Walks.
  • Participates in the definition of the operational improvement strategy and the portfolio of continuous improvement projects.
  • Plays a key role in the prioritization of improvement actions based on available resources.
  • Analyzes all aspects of PU performance, identify and encourage continuous improvement through use of OpEx tools and methodologies, e.g. brainstorming, RCIs, debottlenecking studies and implementing best in class solutions.
  • Supports Process Team Leads in Execution of identified improvement projects.
  • Projects toll gate reviews including capture and validation of financials with BPA.
  • Promotes proactivity Vs reactivity concerning the appearance and treatment of issues around the production process. 

Other related duties as assigned.

Qualifications

  • Bachelor degree in pharmacy, engineering, chemistry, biology, biotechnology or related (higher degree preferred) with 8 years' experience in pharmaceutical or life science industry in a GMP environment, preferably in commercial manufacturing or completed vocational training with 10 years equivalent job experience.
  • 3 year experience in an Expert role in GMP environment - preferred.
  • Solid Experience in Lean Management, Operational Excellence certificate.
  • Experience in a team/people management role.
  • Excellent oral, written and presentational skills.
  • Team player with ability to foster stakeholder Engagement.
  • Objective Setting and Performance Management, Lean Management.
  • Strong negotiator, Influencing and persuading.
  • Change management, adaptability, ability to work under pressure.
  • Strong understanding of the planning and execution activities within the tactical horizon.
  • Good understanding or capacity to quickly understand production processes.
  • Project management /statistical analysis tools/ operational excellence.
  • Good working knowledge of regulatory requirements across multiple health authorities.
  • Good working knowledge of manufacturing execution systems (MES, SAP, or other as applicable).

 

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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