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Contract Development and Manufacturing Manager

Amgen

Singapore

On-site

USD 80,000 - 120,000

Full time

18 days ago

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Job summary

An established industry player is seeking a Contract Development and Manufacturing Manager to oversee external partnerships in the Asia Pacific region. This pivotal role involves managing clinical and commercial supply chains, ensuring compliance with Good Manufacturing Practices, and supporting technology development. The ideal candidate will have a strong background in synthetic drug development and project management, along with excellent interpersonal skills to collaborate with diverse teams. Join a forward-thinking organization that values innovation and offers opportunities for career advancement in a supportive environment.

Benefits

Generous Total Rewards Plan
Opportunities for advancement
Diverse and inclusive community

Qualifications

  • Advanced degree in relevant field with significant experience in drug development.
  • Strong understanding of regulatory requirements and quality management.

Responsibilities

  • Oversee external programs ensuring compliance and product quality.
  • Manage budgets and financial forecasting for projects.
  • Coordinate shipment of materials and manage quality aspects.

Skills

Synthetic drug development
cGMP knowledge
Project management
Interpersonal skills
Change management
Quality management

Education

Doctorate in Synthetic Organic Chemistry
Master’s with 2 years experience
Bachelor’s with 4 years experience
Diploma with 8 years experience

Job description

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, bringing state-of-the-art medicines from laboratory to the patient. Amgen has discovered and developed innovative human therapeutics and invested in cutting-edge manufacturing capability to deliver these therapies globally. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen, and a Contract Development and Manufacturing Manager is needed in Amgen Singapore Manufacturing.

Live
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 Asia Pacific region, ensuring uninterrupted clinical and commercial supply. This role is within the Synthetic Small Molecule Drug Substance business unit of ACDM, focusing on late-phase clinical and commercial portfolios. It involves supporting technology/process development, supplier onboarding, relationship management, oversight of manufacturing activities, and implementation of sourcing strategies.

The ACDM team is part of the External Supply Organization within Amgen Manufacturing, responsible for developing and implementing the external sourcing strategy for Amgen’s portfolio from early phase through commercial delivery, ensuring adherence to Good Manufacturing Practices (cGMP) and ACDM business practices.

Main Responsibilities:
  • Day-to-day oversight for external programs and deliverables.
  • Overseeing ongoing activities at selected sites to ensure compliance, timelines, product quality, and cost.
  • Collaborating with internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation requests.
  • Financial management of budgets (OPEX, CAPEX, COGM), forecasting, and handling purchase orders and invoices.
  • Coordinating shipment of materials/samples between sites.
  • Managing quality aspects of site engagement, including deviation investigations and change management.
  • Performing other related duties as assigned in external supply.

These tasks are essential functions of the position, but business conditions may require reasonable accommodations for additional tasks.

Win
What we expect of you
Basic Qualifications
  • Doctorate in Synthetic Organic Chemistry, Chemical Engineering, or Life Sciences; or Master’s with 2 years experience; or Bachelor’s with 4 years experience; or Diploma with 8 years experience in a related field.
  • Knowledge of synthetic drug development and manufacturing.
  • Understanding of cGMP, Operations, and Regulatory/CMC requirements.
  • Experience with CRO and CDMO relationships.
  • International experience in JAPAC, especially India and China.
  • Experience in change management, deviation investigations, and implementing corrective/preventive actions.
  • Understanding of tech transfer, drug development, and commercialization of synthetic therapeutics.
  • Experience in cross-functional settings, as a team member or leader.
  • Strong project management and coordination skills.
  • Strong interpersonal and communication skills.

Your selection for this role will be subject to medical requirements. All medical expenses incurred for medical checks will be borne by the company.

Thrive
What you can expect of us
  • Opportunities to learn and advance within our global organization.
  • A diverse and inclusive community where ideas are welcomed.
  • A generous Total Rewards Plan including health, finance, and career benefits.
Apply now

Join us in our commitment to serve patients. Amgen is an Equal Opportunity employer, considering applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We provide reasonable accommodations for individuals with disabilities to participate in the application process and perform essential job functions.

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