Amgen

Technical Specifications Sr Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-76928
Required Education
High School or equivalent
Position Type
Full time
As part of new Specification team, this position will provide management of the raw material specifications through all phases of their life cycle. Candidate will oversee the early engagement process to support development of comprehensive specifications that will ensure quality raw materials are consistently delivered to Amgen. Specification management responsibility includes coordination with Regulatory, Compliance, Quality, and Operations when changes to specifications are required.

This position reports into the Raw Material team within External Supply and includes oversight of direct reports. Being a newer department within Eternal Supply, this position will play a major role in shaping the department's current operations as well developing a strategy for the future.

Responsibilities to include:

Develop, revise and implement raw material specifications and procedures that comply with regulatory requirements

Act as Subject Matter Expert advocate for raw material issues and initiatives

Work on projects to drive continuous improvement activities for material specification processes across functions and sites

Participate in raw material qualification, raw material commercialization, and second sourcing efforts

Perform supplier and material risk assessments

Resolve bottlenecks related to key changes

Negotiate with management in multiple sites/organizations to secure resources and timeline commitments

May serve as a topic expert and resource to others

Facilitation of meetings to resolve key issues

Manage / train junior staff

Basic Qualifications

Doctorate degree and 2 years of Operations experience OR

Master's degree and 6 years of Operations experience

OR

Bachelor's degree and 8 years of Operations experience

OR

Associate's degree and 10 years of Operations experience

OR

High school diploma / GED and 12 years of Operations experience

Preferred Qualifications

Master's Degree in Chemistry or Biological Sciences/Life Sciences

Working knowledge of major pharmacopeias.

5+ years of Operations experience in the pharmaceutical or medical device industry

Previous experience in technical aspects of materials management

Broad technical knowledge of raw materials, testing and specification generation

Experience in working with and/or knowledge of how raw materials are used in manufacturing processes

Project management skills

Strong written and verbal communication skills

Ability to interpret and apply compliance and quality requirements (FDA, EME, ICH etc.)

Ability to work independently as well as on teams

Ability to prioritize and manage multiple tasks, including multiple assignments and processes

Ability to work efficiently and effectively in a challenging and fast-paced work environment

Ability to create procedures and processes to drive desired results

Ability to apply analytical skills to evaluate and interpret complex situations/problems

Ability to interact with regulatory agencies and external parties

Emphasis in Excipient Elemental Impurities

Experience with executing risk assessments using various risk tools (FMEA, PrHA etc.)

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.