Job Description
Contract Development and Manufacturing Manager Amgen Technology Ireland HOW MIGHT YOU DEFY IMAGINATION? Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Amgen Technology Ireland are now hiring a Contract Development and Manufacturing Manager, this position will be remote based. Contract Development and Manufacturing ManagerLive What you will do The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified candidate to manage Amgen's external network of development and manufacturing partners in the European region to ensure uninterrupted clinical and commercial supply for Amgen's portfolio. The position will be in the Synthetic Small Molecule Drug Substance business unit of ACDM and will focus on Amgen's clinical and commercial portfolio. This is a key role in a high-performing cross-functional, global organization and will support technology / process development, supplier onboarding and relationship management, oversight of manufacturing activities, and implementation of sourcing strategies (e.g., scope of work, proposal request execution, participation in site selections) The Amgen Contract Development and Manufacturing team is part of the External Supply Organization within Amgen Manufacturing. This team develops and implements the external sourcing strategy for Amgen's portfolio from early phase through commercial delivery. Amgen Contract Development and Manufacturing leverages a network of global assets to create exceptional value for Amgen and deliver vital medicines forour patients. This role will support engagement and oversight of Contract Development and Manufacturing Organizations (CDMO's) through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices. Main Responsibilities : The successful candidate will demonstrate a strong desire to work in Amgen's external Synthetic Drug substance manufacturing network, leading clinical and commercial programs. The ability to build and maintain relationships, internally and externally, is critical. Understanding of commercial supply to develop a robust supply chain is an advantage. Key responsibilities of this role include: Day-to-day oversight for external programs and deliverables Overseeing ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and cost Working closely with the ACDM team and internal stakeholders (Quality, Supply Chain, Process Development) to support sourcing activities, including generating and managing scope of work (SoW) and quotation request documents Financial management of budget (OPEX, CAPEX and COGM), financial forecasting and management of purchase orders and invoices Coordinating requests for shipment of materials/samples between sites Overseeing quality aspects of the site engagement, such as deviations investigations and change managements as needed Performing other related duties and tasks as necessary or as assigned, potentially in other areas of external supply All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. WinWhat we expect of you Basic Qualifications Doctorate degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences OR Master's degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 2 years of directly related pharmaceutical industry experience OR Master's degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 4 years of directly related pharmaceutical industry experience OR Diploma in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 8 years of directly related pharmaceutical industry experience Preferred Qualifications Knowledge of synthetic drug development and manufacturing Understanding of cGMP, Operations and Regulatory/CMC policies and requirements Experience with interfacing and managing CRO and CDMO relationships Experience with change management, deviation investigations and implementation of corrective/preventive actions Understanding of tech transfer, drug development and commercialization of synthetic therapeutics Experience working in cross-functional settings Experience as a team member or leader of cross-functional or matrix team Strong Project management and coordination skills/experiences Strong interpersonal relationship and communication skills both written and verbal Your selection for this role may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company. Thrive What you can expect of us As we work to develop treatments that take care of others, we work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply nowfor a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.