Principal Product Quality Leader (Synthetics)
Amgen
Summary
In this vital role you will provide technical expertise and product leadership to the Product Quality organization. As a product expert in Quality, the Principal Product Quality Leader has responsibility for working with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects, issue resolution, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
Job description
This role will support one or more of Amgen's synthetic products. The individual will provide technical expertise and project support to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Product Development Team goals. The individual will be directly responsible for Product Quality related tasks including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (change control, data systems, etc), and product data management, including comparability assessments, annual product reviews, and product quality risk assessments.
Key Responsibilities include:
- Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercial synthetic programs, including actions required for the PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
- Support science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
- Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
- Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Requirements
- Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience
- Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience
- Bachelor’s degree & 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
- B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
- 6+ years working in a regulated environment (either direct GMP or technical support)
- 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
- 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of pharmaceutical development
- Understanding of synthetic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
- General knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
- Experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
- A strong foundation in chemistry and experience with new synthetic modalities/ technologies such as peptides, siRNA, new extended release formulations, and or combination products is a plus
Benefits
- Retirement and Savings Plan
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Time-off plans
- Flexible work models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.