Contract Development & Manufacturing Manager

Amgen Foundation, Inc.; Dún Laoghaire; Hybrid; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

Amgen is seeking a Site Lead for Contract Manufacturing Organizations (CMOs) to act as the single point of accountability between Amgen and external partners for Drug Product and Finished Drug Product. You will develop and lead robust operations processes, manage budgets, and drive continuous improvements across contract sites.

Responsibilities include managing site performance, leading project transfers, and coordinating product transfers to contract sites while ensuring risk management and

Qualifikationen

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

Aufgaben

• Manufacturing operations: Develop and lead robust business processes, maintain relationships with contract site management and forecast.
• Site performance monitoring: Manage contract site performance and drive improvements.
• Project Management and Technology transfer: Lead department-wide projects from conception to implementation and coordinate product transfer activities.

Kenntnisse

Negotiation

Project management

Budgeting

Team leadership

Operational excellence

Ausbildung

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

Jobbeschreibung

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.

Summary:

• Site lead for Contract Manufacturing Organizations (CMOs).


• Single point of accountability and interface between Amgen and assigned external partners.


• Drug Product, Finished Drug Product

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, lead site operating review meetings;


• drive improvements at contract sites;


• sustain and improve the overall health of the business,


• 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.

Qualifications: Minimum requirements (as per standard)Preferred Requirements:

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


• · 5+ years of experience in protein DP, or packaging manufacturing environment


• · 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles


• · 2+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products


• · 1+ years of project management experience leading multi-functional and multi-location team


• · 1+ years of experience across ACM or CMQ


• · Ability to travel +/- 20% of time (domestic and international)

Competencies:

• · Demonstrated competencies of lower GCF levels.


• · Demonstrated matrix management and influencing skills.


• · Manufacturing and cGMP knowledge / experience.


• · Demonstrated negotiation skills.


• · Operational Excellence proficiency and ability to drive continuous improvement.


• · Financial/budgeting knowledge and business acumen.
  
• · Proficient project management skills.


• · Problem-solving and critical thinking.


• · Understanding of contractual requirements.


• · Technical writing and multi-level communication skills.


• · Demonstrated ability to lead effectively in collaborative/team environment.


• · Demonstrated ability to take initiative, drive action, and work under minimum supervision.

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.

As an organization dedicated to improving the quality of life for people around the world, 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 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 accommodation.