Manufacturing Manager - Site Lead - ACDM

<h2><b>Career Category</b></h2>Manufacturing<h2></h2><h2><b>Job Description</b></h2><p><b><u><span>Summary:</span></u></b></p><p>Site lead for Contract Manufacturing Organizations (CMOs). <br />Single point of accountability and interface between Amgen and assigned external partners.</p><p></p><p><b><u><span>Responsibilities:</span></u></b></p><p><b><span>Manufacturing operations</span></b>: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.</p><p></p><p><b><span>Site performance monitoring</span></b>: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead <span>communication/relationship</span> with the contract site as well as internal management.</p><p></p><p><b><span>Project Management and Technology transfer</span></b>: Lead a department-wide project from conception to implementation and close-out.  Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.</p><p></p><p><b><u><span>Qualifications:</span></u></b></p><p>Minimum requirements (as per standard)</p><p>Preferred Requirements:</p><ul><li>Bachelor’s in Business Administration, Engineering, or Science-related field</li><li>5&#43; years of experience in DP, or packaging manufacturing environment</li><li>5&#43; years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles</li><li>2&#43; years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products</li><li>1&#43; years of project management experience leading multi-functional and multi-location team</li><li>1&#43; years of experience across ACDM</li><li>Ability to travel &#43;/- 20% of time (domestic and international)</li><li>Location: Ireland</li></ul><p></p><p><b><u><span>Competencies:</span></u></b></p><ul><li>Demonstrated competencies of lower GCF levels.</li><li>Demonstrated matrix management and influencing skills.</li><li>Manufacturing and cGMP knowledge / experience.</li><li>Demonstrated negotiation skills.</li><li>Operational Excellence proficiency and ability to drive continuous improvement.</li><li>Financial/budgeting knowledge and business acumen.</li><li>Proficient project management skills.</li><li>Problem-solving and critical thinking.</li><li>Understanding of contractual requirements.</li><li>Technical writing and multi-level communication skills.</li><li>Demonstrated ability to lead effectively in collaborative/team environment.</li><li>Demonstrated ability to take initiative, drive action, and work under minimum supervision.</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.