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Senior Project Manager

Job Title: Senior Project Manager
Employer Name: Amgen
Web Site: http://www.amgen.com/careers
Contact Name: Amgen
Contact Email_Confirm: n/a
Business Type: Industry
Job Type: Corporate Management
Job Country: US
Job Location: Seattle, WA

Background:

As the largest biotechnology company in the world, Amgen offers the chance to truly innovate and contribute to the big picture in science. Our R&D focus on nephrology, oncology, inflammation and bone disease, and neurology has already produced six marketed products and a promising pipeline of new human therapeutics to come. A world-class sales force, global manufacturing operations, and clinical development sites on three continents complete our picture as a Fortune 500 company and leading biotechnology company committed to improving people’s lives.

Duties:

Senior Project Manager-Product Quality Leader (Job ID#amge-00019749)

Job Summary:
The successful candidate will be a senior Product Quality Leader (PQL) for at least two of Amgen's clinical products. The individual will provide technical expertise and leadership to a Product Quality Team to develop, implement, and manage strategy for Quality to meet project goals along the commercialization lifecycle.

Specific Job Duties:
1. Lead the Product Quality Team (PQT) to manage all aspects of product development in Quality: planning, implementation, monitoring, completion, and follow-up. Manage competing timelines and prioritize critical tasks in Quality.
2. Lead the product development strategy for Preclinical through Phase 3 products in Quality. Provide input into commercialization planning and communicate strategies back to Quality functional areas and Product Quality Team members.
3. Develop and deliver the Product Quality Plan to Quality management along with associated decisions and issues. Implement the Product Quality Plan and be responsible for its outcomes. The Product Quality Plan may span multiple sites and involve collaboration with external development partners or a third party.
4. Investigate and resolve complex product quality issues to meet scientific, regulatory, productivity, quality, and cross functional goals and objectives.
5. Liaise between Operations, Process Development and Quality senior and line management to communicate product quality issues and align global operations guidance with budgets and product goals.
6. Communicate with regulatory agencies (e.g. FDA) on product quality issues.
7. May lead other initiatives to establish local or global processes to support the PQL role.
8. May supervise and review the work of other PQLs.

Qualifications:

Requirements:
Bachelor's degree in physical sciences, life sciences, engineering, or a related field required. Advanced degree (M.S., Ph.D.), strongly preferred. 8+ years of biotechnology/pharmaceutical experience, including at least 2 years of direct experience leading a team also required. General experience in a development (process, formulation, analytical), quality, or GMP manufacturing environment, as well as experience in managing a product through regulatory filings.

Additional_Information:

To learn more about other Amgen opportunities throughout the country, and to apply online, please visit www.amgemn.com/careers (search under location and Job ID#).

As an EEO/AA M/F/D/V employer, Amgen values and encourages diversity in the workplace.