External Supply – Manufacturing Support – Assoc Director

External Supply – Manufacturing Support – Assoc Dir Manufacturing Support

Job Summary:

The External Supply Associate Director of Manufacturing support will report directly to the Executive Director Manufacturing for External Supply and will join the ACDM (Amgen Contract Development and Manufacturing) leadership team.

They will apply their extensive leadership experience to establish, build and advance a newly established and centralized organization which will ultimately have responsibility for manufacturing support of all Drug Substance, Drug Product, Inspected Drug Product and Finished Drug Product manufacturing operations in External Supply.  

This centralized organization will be composed of Process Owners (specialised in capabilities including aseptic filling operations, visual inspection and peptide manufacturing) who will apply their technical depth & expertise to drive execution excellence in a consistent manner across our network of external sites.

Primary responsibilities:

The Associate Director of Manufacturing Support is responsible for managing the life cycle and day to day production support requirements associated with the products, process and systems in our external manufacturing network and so specific responsibilities include:

• Serving on the ACDM leadership team
• Providing leadership to the organization that provides manufacturing support to identify and resolve manufacturing, process and system issues associated with external manufacturing operations
• Developing and implementing a departmental strategy which aligns with the broader organizational strategy
• Ensuring external manufacturing associated metrics and measures meet requirements
• Delivering on headcount, productivity and budget targets
• Effectively collaborate with key customers and support groups in External Supply and across the Amgen Network to ensure best practices are applied to assigned CMOs.
• Build, develop and retain a diverse and high performing team
• Responsible for product lifecycle management and associated electronic batch records as well as for the support of new product introductions and capital projects being implemented into manufacturing within CMOs.
• Responsible for the Process Owner organization which provides process support for all external manufacturing areas, including support for process improvement and aseptic compliance and supporting manufacturing in delivering supply to patients.
• Driving improvements to the investigation process, right first-time investigation reports and records
• Leading manufacturing support related activities for ensuring major deviations are robust, comprehensive and compliant as per procedures and that deviation closure timelines meet requirements to enable supply of product to our Patients
• Lead and support regulatory inspections for manufacturing-support related activities
• Driving continuous improvements to business processes within external manufacturing.

Competencies/Skills:

This individual must already have a proven track record over an extended period of successfully leading multi-functional, cross-site teams.

The individual must also have experience of building and implementing strategy, interacting across Amgen’s manufacturing network and experience of interacting with and reporting out to leadership teams at a site or network level.

This role will require an ability to regularly travel to sites in our CDMO network and an ability to work successfully in a highly international environment.

Industry Experience

• 8+ years of experience in pharmaceutical Manufacturing positions
• 4+ years management experience
• Bachelor’s Degree or combination of education and/or years of experience

Preferred Experience

• Knowledge of applicable regulatory guidelines
• Analytical problem-solving skills
• Clear communicator both vertically and horizontally through multiple channels
• Ability to motivate and enable cross-functional collaboration
• Comfort with complexity and ambiguity with an ability to see the big picture
• Ability to collect, digest and assemble information to enable decision-making
• Ability to partner with other departments
• Considerable organization skills
• Project management skills
• Strong communication skills, verbal and written
• Understanding of formal Risk Assessment tools
• Experience in coaching, mentoring and counselling
• Ability to deal with and manage change
• Ability to set goals and manage them to completion
• Team leadership skills:  Supervision, influencing, delegation, coaching and mentoring, conflict resolution across permanent and contract staff

Basic Qualifications

• Master's degree and 6 years of Manufacturing / Operations experience OR
• Bachelor's degree and 8 years of Manufacturing / Operations experience OR
• Leadership Experience of directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Preferred Qualifications

• Degree in Biology, Chemistry, or Engineering.
• Experience with cGMP Production environments and an understanding of its regulatory requirements.
• Proven leadership and demonstration of process continuous improvement.
• Experience with deviation investigations and CAPAs.
• Demonstrated ability with project management (principles and techniques), initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development.
• Experience participating in, managing, and responding to corporate audits/regulatory inspections.
• Ability to clearly communicate status of the investigation to leadership and to auditors and inspectors.
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners.
• Analysis of complex problems and delivery of clear and timely feedback.
• Strong interpersonal skills.