Process Development Scientist - Pre Pivotal Drug Product

Amgen is currently seeking a Process Development Scientist for our Pre-Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group is responsible for early stage drug product formulation development for multiple modalities. Additionally, the position will develop novel formulations (liquid, lyophilized and frozen). The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the early stage drug product development process.

Responsibilities include:

• Participate in the planning, design, execution, and documentation of laboratory studies related to formulation and fill/finish process development in support of product commercialization.

• Conduct stability studies, including preparation of liquid frozen and lyophilized formulations. This will involve knowledge of ultrafiltration-diafiltration and other buffer exchange processes. A solid understanding of lab scale sterile filling into vials and syringes will be needed.

• Execute development of protein drug formulations, analytical characterization of proteins, development of chromatographic and electrophoretic assays (UPLC/HPLC, SEC, CEX, RP-HPLC, CE-SDS and cIEF). Additional responsibilities include documenting and retrieving scientific results in HLEE notebooks and computer files for regulatory filings, participating in group and project meetings, and presenting at departmental seminars.

• Perform data analysis using advanced statistical/analytical techniques with statistical analysis software as needed.

• Author and review guideline documents, technical protocols, reports, and regulatory sections in support of IND application submissions.

• Deliver progress reports and presentations to ensure management awareness and engagement of the status, advancement, and future program functional needs within Operations.

• Ability to operate with principles of a safe laboratory environment.

Basic Qualifications:

Doctorate degree or Doctorate Degree completed by July 2019

OR

Master's degree & 4 years of scientific experience

OR

Bachelor's degree & 6 years of scientific experience

Preferred Qualifications:

• PhD in Biochemistry, Chemistry, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline with experience in pharmaceutical development and manufacturing

• Working experience with Protein Analytical methods: Solo VPEHPLC/UPLC, Capillary Electrophoresis, Particle analysis, Moisture analysis, Biophysical techniques such as CD and Fluorescence, Analytical centrifugation, light scattering (DLS, SLS)

• Thorough understanding of the lyophilization process for developing lyophilized drug products

• Knowledge of ultrafiltration-diafiltration and other buffer exchange processes

• Solid understanding of lab scale sterile filling into vials and syringes

• Should have fundamental knowledge of instrumental analysis, analytical chemistry and protein biochemistry

• Proficient troubleshooting skills regarding laboratory analytical instruments

• Strong teamwork, organizational skills, attention to detail and accuracy, excellent written and oral communication skills

• Capable of quick learning and multitasking

• Capable of learning a variety of computer software including software for electronic notebooks

• Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation

• Proven ability to learn and act on dynamic information at a rapid pace

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.