Associate Director, Engineering

Due to continued growth and investment, our company is hiring-an Associate Director, Engineering within Biologics External Manufacturing Technology.

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The Associate Director will-be the key technical leader interface between our company and External Partners-for the Biologics External Manufacturing-(ExM)-organization.

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This individual will create, lead and execute technical transfers to and commercial supply from External Partner(s).

-The candidate will be based in the US on the west coast and report to the Director, Biologics-External Manufacturing-Technology.

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The-ideal-candidate will be someone who can navigate a complex network of drug substance nodes across biologics modalities and tech support models.

-The-candidate needs to collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the-External-Partner(s).

-This individual will be capable of leading several high-impact, complex, cross-functional divisional teams and will provide significant leadership to the department.

-This role is critical to the organization's ability to support new and in-line commercial product technology transfers to-External-Partnerships, and support of our in-line products, with sharp oversight and technical risk management, focus on the rapidly expanding biologics third party network.

The-Associate Director, Engineering within Biologics External Manufacturing Technology-is accountable for achieving excellence in Compliance, Supply, Continuous Improvement & Cost Reduction in partnership with our internal technical partners and-External Partner (EP)-leadership, supporting the Vaccines and Biologics businesses.

- This individual works in collaboration with the-Focus Factory Operations lead,-modality specific-Technology-Leads, Large Molecule External Quality Assurance, and Procurement.

---The Associate Director must have biologics manufacturing experience, with broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills.

• Provides-a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites,-and Commercialization.
  
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• Provides-technical oversight, management, and planning support for complex partnership models.
  
  - Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues-
• Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.
  
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• Provides-technical guidance-to the-External-Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
  
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• Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate-External-Partner(s)-for inclusion in the-Company-Network.
  
  - Executes technical due diligence assessments at-External-Partner(s).
  
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• Ensures-tech transfers are positioned for successful business outcomes.
  
  -- Executes technical transfers-and-receiving site readiness activities.
  
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• Leads team for identification and assessment of partner-risks and develops mitigations plans.
  
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• Develops and executes validation strategies for new and existing products.
  
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• Provides-manufacturing process support to-External-Partner(s)-to resolve production issues and to provide guidance on process and capacity optimization.
  
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• Ensures-targeted communications and alignment across technical functions.
  
  - Guides and coaches' others in change leadership.
  
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• Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites-
• Determines-resource plans across all relevant technical functions.
  
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• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.
  
  --Minimizes-duplication of efforts between External Partner and Company-systems.
  
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• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility-
• In concert with Commercialization, Quality, and Regulatory, ensures that-External-Partner(s)-are inspection ready for all new product introductions and transfers.
  
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• Understands the true regulatory requirements and partners with Operations, Quality, and the External…