Amgen Specialist Stability in Juncos, Puerto Rico
The Specialist Stability will provide technical support to the Product Quality (PQ) organization by working within a team environment. The Specialist Stability role will be responsible for the creation, review, verification, and archival of product quality technical data supporting Amgen's clinical and commercial programs and manage stability studies.
SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Own and manage the historical product quality data sets and serve as a primary author or partner closely with key stakeholders to draft PQ/stability owned regulatory filing sections.
Authoring and review of documents, and execution of transactions in relevant GMP systems (change control, LIMS, etc.)
May support site audits.
Coordination and problem resolution within multiple departments (manufacturing, process development, Quality control, etc.).
Master's Degree and 3 years of Quality experience
Bachelor's Degree and 5 years of Quality experience
Educational background in biochemistry, biology, protein/biotechnology sciences
Familiar with quality, compliance and regulatory requirements, and knowledge of analytical techniques used for biologics product quality control.
Experience in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Familiarity with product stability requirements for biologic and small molecules.
Understanding of biopharmaceutical bulk and drug product development and manufacturing.
Strong project management skills.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
Previous experience working on a cross-functional team in a matrix environment.
Excellent written and verbal communication skills, including facilitation and presentation skills.
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.
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.