AD, Manufacturing Technical Support
AD, Manufacturing Technical Support
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Job Description
Band
Level 5Job Description Summary
#LI-OnsiteThis role is based in Durham NC.
The Associate Director Manufacturing Technical Support oversees the Manufacturing Technical Support team in coordinating and planning activities with end-to-end manufacturing responsibility including manufacturing clinical programs deviation management logistics project work operational excellence resources and budget/costs. This role also ensures compliance with quality standards Health Safety and Environment (HSE) regulations Good Manufacturing Practices (GMP) customer service requirements statutory obligations regulatory standards and Novartis guidelines.
Job Description
Role Responsibilities:
- Lead and manage the Manufacturing Technical Support team ensuring alignment with strategic objectives and action plans.
- Cultivate and sustain trust and respect among team members promoting a culture of empowerment and accountability.
- Oversees recruitment training coaching and performance processes to meet operational requirements. Facilitates career path development and succession planning for the unit.
- Oversee compliance activities for batch release ensuring adherence to Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations.
- Manage quality events including escalations investigations and implementation of corrective and preventive actions (CAPA). Ensure proper application of change control processes and consistency in decision-making.
- Oversee production documentation flow and ensure consistency with GMP standards.
- Promote and improve Safety and Quality cultures ensuring overall inspection readiness and compliance with Novartis policies.
- Drive Lean culture and continuous improvement initiatives utilizing Lean Leadership and Operational Excellence tools.
- Support Process Team Leads in executing identified improvement projects and ensuring effective resource allocation.
- Other related duties as assigned.
Role Requirements:
- Bachelors 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.
- Solid experience in Lean Management and Operational Excellence.
- Proven experience in a team/people management role with strong stakeholder engagement skills.
- Excellent oral written and presentation skills along with strong negotiation and influencing abilities.
- Demonstrated capacity to manage change adapt effectively and maintain high performance under pressure.
- Strong understanding of production processes regulatory requirements and manufacturing execution systems (MES SAP or other).
Desirable Requirements:
- 3 years experience in an Expert role in GMP environmentpreferred.
Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $138600 to $257400/yearly. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other benefits. In addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves. To learn more about the culture rewards and benefits we offer our people click here.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Assembly Language Biotechnology Business Networking Change Control Chemistry Continual Improvement Process Cost Reduction General Hse Knowledge Incentive Program Knowledge Of Gmp Leadership Lean Manufacturing Learning And Development Manufacturing Process Manufacturing Production Operations Productivity Risk Management Root Cause Analysis (RCA) Six Sigma Technology TransferEmployment Type
Full-Time
