Principal Product Quality Leader (Biologics)

BioSpace; Washington (District of Columbia); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Flexible work model

Job summary

Amgen is seeking a Principal Product Quality Leader to provide technical leadership within the Product Quality Team, interfacing with International Distribution Quality, Regulatory, and Manufacturing to drive product improvements and investigations. You will own regulatory filings, comparability, stability programs, and quality risk assessments for late-stage and commercial biologics.

The role emphasizes cross-functional collaboration, strong data management, and the ability to navigate global

Qualifications

• Doctorate with 2+ years of Quality, Operations, Scientific, or Manufacturing experience.
• Masters with 4 years of Quality, Operations, Scientific, or Manufacturing experience.
• Bachelors with 6 years of Quality, Operations, Scientific, or Manufacturing experience.
• Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience.
• High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience.

Responsibilities

• Provide cross-functional quality leadership for late phase and commercial programs, including annual product reviews, specifications, comparability and stability programs; site and method transfers; product quality impact assessments; and PQ-owned regulatory filing sections.
• Support science and risk-based evaluation of complex process and product quality data, including developing patient-oriented strategies that account for business needs and/or provide novel solutions.
• Author GMP/Regulatory documents and manage product data as part of the Product Quality Team to meet development goals.

Skills

Communication

cGMP knowledge

Regulatory understanding

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Amgen is seeking a Principal Product Quality Leader to provide technical leadership within the Product Quality Team, interfacing with International Distribution Quality, Regulatory, and Manufacturing to drive product improvements and investigations. You will own regulatory filings, comparability, stability programs, and quality risk assessments for late-stage and commercial biologics.

The role emphasizes cross-functional collaboration, strong data management, and the ability to navigate global