Process Development Associate
Amgen is seeking a Process Development Associate to join the Commercial Attribute Sciences team and work from our beautiful Thousand Oaks, CA campus. This position will be within our Commercial Attribute Science Large Molecule Release Testing group in Process Development. The focus of this position is on analytical testing and method qualification to support earlier phase clinical product testing in a GMP laboratory to advance Amgens portfolio. The successful candidate will perform release and stability testing in a GMP laboratory in support of early phase clinical process and product development for Amgens pipeline.
Primary responsibilities include the following:
- Performing routine laboratory procedures
- Execution of HPLC, UHPLC, and CE experiments for routine analytical testing of bio-therapeutic proteins following cGMP requirements and internal phase appropriate GMP procedures
- Document, analyze, and report results following GDP and GMP requirements including routine documenting, computing, compiling, interpreting, and entering data from routine analysis
- Maintaining and operating specialized equipment
- Initiating and / or implementing changes in controlled documents.
- Transfer and qualify analytical methods under guidance of a senior member of the Attribute Sciences team
- Author, review, and data verify technical documents and standard operation procedures
- Must learn and comply with safety guidelines and cGMPs/CFRs, which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks
- Bachelors degree OR
- Associates degree and 4 years of scientific experience OR
- High school diploma / GED and 6 years of scientific experience
- Strong analytical lab skills and technical knowledge of proteins and peptides
- Strong organization skills and acute attention to details
- Proficient using HPLC and UHPLC
- Experience with capillary electrophoresis
- Familiarity with GMP regulations, experience with EMPOWER, LIMS (laboratory information management systems), and 32 Karat software is a plus
- Ability to follow established protocols and procedures, and ability to develop new or revise existing protocols and procedures as needed
- Strong computer and scientific skills, proficient in Microsoft Excel, Word, and PowerPoint
- Excellent communication (oral and written) skills
- Ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Educational background in Chemistry, Biochemistry, or related Life Sciences
- Some working experience in cGMP environment
- Strong organizational skills, including ability to follow assignments through to completion
- Strong word processing, presentation, database and spreadsheet application skills
- Strong communication (both written and oral), facilitation and presentation skills
- Excellent organizational skills and a great attention to detail
- Ability to make independent decisions based on system output
- Self-motivated, able to interface effectively with various levels, and able to prioritize to meet deadlines
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
Join UsIf 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.