Contract Development

2 weeks ago

Singapore Amgen Full time

**Contract Development and Manufacturing Manager**

**Amgen Singapore Manufacturing**

**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. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a **Contract Development and Manufacturing Manager **in **Amgen Singapore Manufacturing**.

**Contract Development and Manufacturing Manager**:
**Live**:
**What you will do**

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 for our 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:

- 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.

**Win**:
**What 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
- Bachelor’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
- International experience working with companies in the JAPAC regions, specifically India and China
- 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

**Thrive**:
**What you can expect of us**

As we work to develop treatments that take care of others, so 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

**for 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.

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