Senior Associate - Process Development (PD) Pre-Pivotal Attribute Sciences (AS)
Attribute Sciences group within Process Development provides scientific and technical expertise to support development and commercialization of Amgens pipeline of drug candidates. The department identifies and coordinates the achievement of desired product quality attributes towards target product profiles, develops and applies fit-for-purpose analytical methodologies. This position is an exciting opportunity to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. To be a part of Amgen, the worlds leading biotechnology company, that reached millions of patients around the world.Job Details:
The candidate will join Large Molecule Release Testing (LMRT) laboratory within Amgen Pre-Pivotal Attribute Sciences Department. Under general supervision, this position will perform routine procedures and testing in support of the LC-CE group (liquid chromatographic analysis using UHPLC/HPLC and capillary electrophoresis using Beckman CE instruments). This position will be responsible for one or more of the following activities in a GMP environment following Amgens phase appropriate GMP procedures:
- Performing routine laboratory procedures
- Routine analytical testing - Documenting, computing, compiling, interpreting and entering data
- Maintaining and operating specialized equipment
- Initiating and / or implementing changes in controlled documents.
- Follow 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.
Job responsibilities include, but are not limited to, the following:
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 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.The ideal candidate would possess:
- 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 is a plus
- Familiarity with GxP 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, resourcefulness, and a positive demeanor
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies
Bachelor's degree and 2 years scientific experience
Associate's degree and 6 years of scientific experience
High School Diploma/GED and 8 years of scientific experiencePreferred Qualifications
- Possess good technical analytical techniques for MS, LC, CE analysis
- Experience with automation and software for use in high throughput lab setting
- Proficient using data analyses software, such as Chromeleon, Empower, and 32Karat
- Excellent communication skills both verbal and written
- Strong organizational and interpersonal skills
- Ability to work independently and as part of a team, self-motivation, flexibility, a positive attitude and proactive approach
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 sophisticated 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 demonstrates 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.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.
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.