Manager-Analytical & Data Verification

Career Category

Quality

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

The Stability function is part of the Amgen Product Quality organization, providing governance and management of lean, harmonized, and compliant Stability data packages for all of Amgen’s products.  In this team-based role, Manager Stability will collaborate with Product Quality Teams (PQTs), supporting specialist teams, and Global stability teams to ensure the design, management, maintenance, and data analysis of a product’s stability program support GMP compliance and meet the Market Authorization commitments. In this management role you will provide critical support to PQTs through management of activities and staff supporting different programs for late-stage clinical and commercial products.

In this team-oriented manager role, you will serve as a subject matter expert of GMP data management strategy, directly adding to the success of PQTs by ensuring support for the product Quality strategies. In this role, you will be working closely with diverse functional groups including Supply Chain, Manufacturing, Global CMC Statistics, External Supplier Quality, Quality Control, Regulatory, Quality Assurance, external providers, and other departments on a variety of activities. Such activities include managing data standardization activities, Chromatographic overlays, data verification and, where warranted, investigations, regulatory submissions and support for inspections across the Amgen manufacturing and testing network.

Roles & Responsibilities:

Directly supervise Quality staff supporting Product Quality Teams and activities enabling regulatory submissions

Adeptly manage staff training and independently coordinate staff assignments supporting time-sensitive activities across multiple teams

Author, revise, review, and approve technical documents in GMP Quality systems, including but not limited to data reports, Standard Operating Procedures, and Work Instructions

Work closely with the global Product Quality organization to drive standardization of data, Chromatographic overlays and data verification activities

Lead continuous improvement projects that may be global or local in scope

Own, manage, and participate in deviations, CAPAs, and cross functional investigations

Communicate and collaborate with cross-functional teams across multiple sites and time zones to coordinate stability study starts and sample requests

Participate in audits and inspections across multiple sites

Mentor and train staff, as required

Basic Qualifications and Experience:

Master's degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and above 10 years of Quality, Operations, Scientific experience.

Functional Skills:

Must-Have Skills:

Experience and expertise in managing teams and motivating staff to deliver high quality results and adhere to project timelines using digital GMP Quality systems

Demonstrated proficiency and knowledge in biologics manufacturing processes including analytical methods, cGMP, and international regulatory expectations

Demonstrated proficiency is oral and written communication of complex information

Ability to build and maintain cross-functional relationships and strong partnerships through written and verbal communication skills

Exceptional attention to detail and accuracy in all deliverables

Strong scientific data management and organization skills

Expertise with chromatography systems, Laboratory Information Management Systems

Expertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., MS Teams)

Effective communication, critical thinking and problem solving

Good-to-Have Skills:

Experience working virtually on a cross-functional team in a matrix environment across multiple time zones

Expertise in computer applications such as Veeva, Spotfire, SHINY

Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)

Soft Skills:

Analytical and problem-solving skills

Ability to work effectively with global, virtual teams

High degree of initiative and self-motivation

Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines

Team-oriented, with a focus on achieving team goals

Strong presentation and public speaking skills

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.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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