Process Development Associate: Process Analytics

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Job description

Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), live oncolytic viruses, and synthetic medicines.

Located in our Cambridge, MA office, the Associate (Process Analytics) position will work to provide testing support for commercial process development and process characterization studies for clinical candidate molecules in the pivotal stage of development.

Responsibilities:

• Transition of analytical methods from our early-stage development teams to the pivotal testing laboratory. This will include interfacing with attribute sciences team leads and early stage development teams, performing method assessment / qualification, method optimization, and formatting chromatography data software methods.
• Performing high-sample volume testing by High Performance Liquid Chromatography (HPLC), Ultra High-Performance Liquid Chromatography (UHPLC), Capillary Electrophoresis (CE), and Tecan in support of Drug Substance, Drug Product, and Attribute Sciences process development teams, under prescribed timelines. Full documentation of analyses in electronic lab notebook. Performing tracking and trend analysis of method performance.
• Hand-off/transfer of testing to our Rapid Analytics teams.
• Evaluation of novel platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams.
• Performing HPLC/UHPLC and CE method qualification studies to support transfer of methods to pivotal Quality Control teams.
• Perform forced degradation studies to support product characterization, understanding of product stability and evaluation of product comparability.
• Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.

Basic Qualifications

• Bachelors degree OR
• Associates degree and 4 years of Scientific experience OR
• High School Diploma / GED degree and 6 years of Scientific experience

Preferred Qualifications

• B.S. in Biochemistry
• Good general biochemistry laboratory skills
• Expertise in chromatography including HPLC, UPLC, and CE
• Experience performing mass spectrometry
• Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
• Strong desire to learn and interest in science
• Demonstrated proficiency in method development and experience with method technology transfer. Background in chromatography data software (Waters Empower, Thermo Chromeleon) and/or automation software (Tecan)
• Understanding of phase-appropriate GMP compliance and documentation
• Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams

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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.