Associate Scientist

Amgen; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Associate Scientist to contribute to early-stage portfolio projects across therapeutic modalities. The role focuses on formulation development and stability characterization of large molecule candidates, ensuring quality attributes support IND readiness.

You will develop drug product formulations and provide scientific expertise across pre-pivotal programs.

Qualifications

• Master’s degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, or related field
• 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 development of parenteral control release delivery systems
• Proficiency in statistical software (e.g., JMP) and data visualization tools (Tableau/Spotfire)

Responsibilities

• Plan, design, and document stability studies for FIH formulation development and fill/finish process development
• Design and execute in-use compatibility studies for clinical dose preparation and administration
• Conduct stability studies for liquid and lyophilized formulations using ultrafiltration-diafiltration and buffer exchange
• Develop multi-modality protein drug formulations and analytical characterization (HPLC/UPLC, mass spectrometry, etc.)
• Participate in cross-functional project teams and present data to stakeholders
• Ensure compliance and quality while meeting organizational goals
• Author and review technical documents, protocols, transfer docs, and IND regulatory sections
• Stay current with industry and scientific developments
• Maintain meticulous data capture and documentation
• Work effectively in a matrixed team and present data cross-functionally

Skills

Scientific research

Formulation development

Stability testing

Data analysis

Education

Master’s degree

Bachelor’s degree with 2 years of scientific experience

Associates degree with 4 years of scientific experience

High school diploma / GED with 6 years of scientific experience

Tools

HPLC/UPLC

Mass spectrometry

Biophysical analysis

Job description

Basic Qualifications:
Master’s degree

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

What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Scientific experience
OR
Associates degree and 4 years of Scientific experience
OR
High school diploma / GED and 6 years of Scientific experience
Preferred Qualifications:

• 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.

What You Can Expect Of Us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.