Associate Director, Engineering

** Job Description*
* ** General

Summary:

*
* Due to continued growth and investment, our company is hiring an  
** Associate Director, Engineering within Biologics External Manufacturing Technology.*
* The Associate Director will be the key technical leader interface between our company and External Partners for the Biologics External Manufacturing (ExM) organization.

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.

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.

** Position Profile:*
* 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.

** Job Details:*
* The primary focus of the Associate Director is to provide technical and project leadership to Biologics External Manufacturing business for:

+ Provides a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.

+ 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.

+ 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.

+ 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).

+ Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.

+ Leads team for identification and assessment of partner risks and develops mitigations plans.

+ Develops and executes validation strategies for new and existing products.

+ Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.

+ Ensures targeted communications and alignment across technical functions. Guides and coaches' others in change leadership.

+ Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites

+ Determines resource plans across all relevant technical functions.

+ Provides a technical review of External Partner process change requests, deviations, and Master Batch…