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Contract Development And Manufacturing Manager

5+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Amgen's Mission of Serving Patients
At Amgen, we are driven by a shared mission to serve patients living with serious illnesses. Since 1980, we've helped pioneer the biotech industry, focusing on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. We reach millions of patients each year, making a lasting impact on their lives. As a member of the Amgen team, you’ll play a vital role in developing, manufacturing, and delivering innovative medicines that help people live longer, fuller, and happier lives.

With our collaborative, innovative, and science-driven culture, if you’re passionate about making a difference, you’ll thrive at Amgen. Join us and transform patients’ lives while advancing your career.


Contract Development and Manufacturing Manager

Location: [Location]
Job Type: Full-time


What You Will Do

In this critical role, you will manage clinical and commercial programs, supporting Amgen’s dynamic portfolio. The role requires you to quickly adapt strategies, build and maintain strong relationships, and ensure the development of a robust supply chain. You will be the key point of contact for CDMOs and CROs, overseeing projects that span from development to commercial manufacturing. Your responsibilities will include:

  • Collaborating with technical and functional leads (Drug Substance, Analytical, Quality, Supply Chain) to execute tactical management of external projects.
  • Supporting internal sourcing activities, including creating and managing scope of work (SoW) and quotation request documents.
  • Managing supplier evaluation, site selection, and outsourcing activities.
  • Ensuring compliance by overseeing quality aspects, resolving issues with manufacturing, deviations, and compliance-related matters.
  • Building and maintaining relationships with internal and external stakeholders to enhance project efficiency.
  • Monitoring and managing budgets, financial forecasting, and purchase orders.
  • Identifying opportunities for continuous improvement in production, cost, quality, and efficiency.
  • Monitoring supplier performance to ensure efficiency and effectiveness.
  • Presenting recommendations and analyses to Senior Management.
  • Occasional travel to support project outcomes.

What We Expect of You

Amgen seeks a professional with leadership qualities and the following qualifications:

Basic Qualifications:

  • High school diploma / GED and 10 years of Manufacturing experience OR
  • Associate’s degree and 8 years of Manufacturing experience OR
  • Bachelor’s degree and 4 years of Manufacturing experience OR
  • Master’s degree and 2 years of Manufacturing experience OR
  • Doctorate degree.

Preferred Qualifications:

  • Advanced degree in chemistry or chemical engineering.
  • Strong understanding of cGMP, regulatory policies, and financial systems.
  • Experience managing CMO and CDMO relationships.
  • Strong quantitative skills with experience in cost of goods analysis, business process development, and performance management.
  • Experience in change management and implementing corrective/preventive actions.
  • Strong project management and interpersonal relationship skills.
  • Ability to analyze and resolve complex issues effectively.

What You Can Expect From Us

At Amgen, we believe in supporting your growth and well-being. Along with competitive benefits, you’ll have access to a Total Rewards Plan, flexible work arrangements, and career development opportunities.

  • Comprehensive benefits package including health, dental, and vision insurance.
  • Retirement and savings plans with generous company contributions.
  • Annual bonus programs and stock-based incentives.
  • Flexible work options to promote work-life balance.