Associate Scientist

Amgen • Thousand Oaks, CA

4d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will contribute to our diverse early-stage portfolio projects that support different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, ADCs and oligonucleotides). The candidate is expected to have hands-on experience in formulation development and stability characterization of large molecule drug candidates to assess their critical quality attributes supporting diverse therapeutic areas. The candidate will be responsible for drug product formulation and process development by providing scientific and technical expertise to advance the pre-pivotal portfolio. Routinely plan, design, complete, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization. Responsible for design and execution of in use compatibility studies for clinical to mimic clinical dose preparation and administration Conduct stability studies, to support liquid and lyophilized formulations. This will require knowledge of ultrafiltration-diafiltration and other buffer exchange processes. Complete development of multi-modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC/2-D HPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis, biophysical analysis. Active participation and representation of drug product process development group in cross-functional project teams across organization Continuous adherence to compliance and quality and compliance while meeting organization’s goals and priorities Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs Meticulous data collection, documentation using electronic data capture systems Ability to work in a matrixed team and present data cross functionally

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of Scientific experience OR Associate’s degree and 4 years of Scientific experience OR High school diploma / GED and 6 years of Scientific experience

Nice To Haves

• Master’s degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, or related field with a minimum of 3+ years of industrial experience in pharmaceutical/biotechnology or related field
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
• Experience in antibody characterization, stability, and experience in development of parenteral control release delivery systems
• Sophisticated understanding of predictive methods, protein stability and solubility
• Preferred experience in biophysical analysis (Light scattering, DSF, AUC, FFF), mass spectrometry (peptide mapping), high throughput screening and data analytics
• Preferred understanding of drug delivery and devices related to product development
• Proficiency in statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire)
• Strong independent problem-solving skills
• Ability to learn and act on dynamic information at a rapid pace, hard-working and collaborative attitude
• Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.

Responsibilities

• Contribute to diverse early-stage portfolio projects supporting different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, ADCs and oligonucleotides).
• Have hands-on experience in formulation development and stability characterization of large molecule drug candidates to assess their critical quality attributes supporting diverse therapeutic areas.
• Responsible for drug product formulation and process development by providing scientific and technical expertise to advance the pre-pivotal portfolio.
• Routinely plan, design, complete, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization.
• Responsible for design and execution of in use compatibility studies for clinical to mimic clinical dose preparation and administration.
• Conduct stability studies, to support liquid and lyophilized formulations, requiring knowledge of ultrafiltration-diafiltration and other buffer exchange processes.
• Complete development of multi-modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC/2-D HPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis, biophysical analysis.
• Active participation and representation of drug product process development group in cross-functional project teams across organization.
• Continuous adherence to compliance and quality while meeting organization’s goals and priorities.
• Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions.
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs.
• Meticulous data collection, documentation using electronic data capture systems.
• Ability to work in a matrixed team and present data cross functionally.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree