Product Quality Specialist

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are Our shared mission?to serve patients living with serious illnesses?drives all that we do Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Diseasewe reach millions of patients each year As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives Our award-winning culture is collaborative, innovative, and science based If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career What You Will Do Lets do this Lets change the world In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole Help us to pave new roads for helping patients This role will support one or more late-stage and/or commercial biologics or synthetics products The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR) In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc What We Expect Of You Basic Qualifications and Experience: Masters degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8-13 years of Quality, Operations, Scientific, or Manufacturing experience Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in Biologics manufacturing process including analytical methods Experience with authoring comparability protocols, product specifications and stability assessments Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Hands-on experience with combination products such as pre-filled syringes (PFS), pen injectors and automatic pen injectors 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 What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture, well support your journey every step of the way In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careersamgen 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 and live the Amgen values to continue advancing science to serve patients Together, we compete in the fight against serious disease 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, disability status, or any other basis protected by applicable law We will ensure that individuals with disabilities are provided 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 accommodation