20 days old

Specialist Manufacturing - Investigations

Amgen
Woburn, MA 01801
  • Job Code
    121551086
Amgen

Job ID: R-101191
Location: Woburn, MA, US 01806

Job Description

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in flawless execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement mindset, and an unyielding focus on safety, quality, and compliance.

The Manufacturing Specialist - Investigations has ownership and management of Class 2 and 3 Nonconformance (NC) investigations and associated Corrective and Preventative Actions (CAPA) at the AWM facility.

Responsibilities include, but are not limited to the following:

General:

Mentoring and leading of peers in functional areas and Quality Operations in the implementation of investigations of varying complexity

Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance

Communication of Quality System status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for site performance

Partner cross-functionally across the site to ensure maturity and execution of robust NC/CAPA process

Support regulatory inspections by directly collaborating with inspectors to present NC/CAPA process overviews as well as individual investigations

Prepare defense strategies in support of regulatory inspections and internal audits

Provide timely and comprehensive process and investigation status updates to senior management

Build and present investigation summaries for Senior Management review

Identify and coordinate an investigation team to include all Amgen key partners and subject matter experts vital for a complete investigation

Develop and lead the implementation of investigation plans for nonconformances

Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Manufacturing or Operations experience

OR

Bachelor's degree and 5 years of Manufacturing or Operations experience

OR

Associate's degree and 10 years of Manufacturing or Operations experience

OR

High school diploma / GED and 12 years of Manufacturing or Operations experience

Preferred Qualifications:

Scientific degree in Life Sciences or Physical Sciences, Applied Engineering or Manufacturing Technologies

Experience leading cross-functional/site investigation teams in complex deviations including determination of potential product impact, root cause, and corrective and preventative actions

Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction

Proven leadership traits

Excellent communication skills, both written and verbal (including technical writing and presentations) with ability to collaborate productively with technical and senior management staff

Ability to solve complex problems and make scientific risk-based decisions

Experience presenting to and interacting with representatives of regulatory agencies

Trackwise database experience

Direct bulk and fill and finish manufacturing experience

Aseptic processing knowledge and/or practical experience

Competencies:

Passion for Operational Excellence

Communications skills, both oral and written, including presentation skills

Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met

Ability to tactfully negotiate and positively influence peers and executive leadership

Analytical skills to identify potential improvement opportunities

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.



PI121551086

Categories

Posted: 2020-07-14 Expires: 2020-08-14

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Specialist Manufacturing - Investigations

Amgen
Woburn, MA 01801

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