Contract Development & Mfg Sr Mgr

Amgen Inc. (IR); Dublin; On-site; EUR 102,000 - 137,000; Full time

Job summary

Amgen is seeking a Contract Manufacturing Senior Manager (Site Lead) to develop and lead robust business processes, manage budgets, contracts, and capacity planning across contract sites. You will drive operational excellence and work closely with external CMOs to ensure reliable performance.

This role requires 8+ years in protein/API/DS/DP or packaging, deep knowledge of cGMP and regulatory guidelines, plus 3+ years of cross-functional leadership.

Qualifications

• Bachelor’s degree required in Business Administration, Engineering, or a science-related field.
• 8+ years in protein, API, DS/DP, or packaging manufacturing environments.
• 8+ years knowledge of cGMP principles, FDA and regulatory guidelines, and validation principles.
• 5+ years working with external parties or leading cross-functional teams for clinical/commercial products.
• 3+ years project management leading multi-functional and multi-location teams.
• 3+ years experience across ACM or CMQ.
• Ability to travel +/- 20% (domestic and international).

Responsibilities

• Develop and lead robust business processes across contract sites.
• Manage budget development, monitoring, and reporting; contracts and information requests.
• Monitor contract site performance using lean tools and PDCA; lead operating reviews.
• Lead department-wide projects from conception to implementation and transfer activities to contract sites.

Skills

Cross-functional leadership

Budget management

Problem solving

Risk management

Education

Bachelor’s in Business Administration, Engineering, or Science-related field

Job description

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Contract Manufacturing Senior Manager (Site Lead) Responsibilities

Manufacturing operations: 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.

Site performance monitoring: 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 communication/relationship with the contract site as well as internal management.

Project Management and Technology transfer: 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.

Preferred Qualifications

• Bachelor’s in Business Administration, Engineering, or Science-related field
• 8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
• 8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• 5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
• 3+ years of project management experience leading multi-functional and multi-location team
• 3+ years of experience across ACM or CMQ
• Ability to travel +/- 20% of time (domestic and international)

Competencies

• Assimilates multiple inputs and allocates resources to potentially conflicting priorities
• Anticipates and resolves complex problems and integrates into continuous improvement
• Establishes and manages business budget
• Strong influence and negotiation skills
• Expertise in problem solving and risk-based decision-making
• Demonstrated matrix management and organizationally savvy
• Promotes and drives organizational change
• Excellent project management skills
• Mastery of contractual requirements
• Demonstrated ability to lead effectively in collaborative/team environment
• Demonstrated ability to take initiative, drive action, and works independently

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range 101,613.25 EUR - 137,476.75 EUR

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodatio n.

Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen