Associate Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision coverage

Life and disability insurance

Flexible spending accounts

Annual bonus

Stock options

Paid time off

Flexible work models

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Associate Scientist to advance stability studies and drug product development across modalities. You will design, execute, and document studies, partner with cross-functional teams, and contribute to IND submissions while maintaining strict compliance.

The role emphasizes analytical characterization, data integrity, and communication of results. A strong background in protein science and pharmaceutical development is required.

Qualifications

• Masters degree is required.
• Bachelors degree with 2+ years of scientific experience qualifies.
• Associates degree with 4+ years of scientific experience qualifies.
• High school diploma with 6+ years of scientific experience qualifies.

Responsibilities

• Plan, design, complete, and document stability studies for FIH formulation development and fill/finish process development.
• Design and execute in-use compatibility studies for clinical dose preparation.
• Conduct stability studies for liquid and lyophilized formulations; knowledge of ultrafiltration-diafiltration and buffer exchange processes.
• Develop multi-modality protein drug formulations and analytically characterize proteins (HPLC/UPLC, MS, etc).
• Participate in cross-functional project teams and represent drug product process development.
• Maintain compliance and quality while meeting organizational goals.
• Author/review guidelines, protocols, transfer docs, reports, and IND sections.
• Stay current on industry developments to drive innovation.
• Meticulous data collection and documentation using electronic data capture systems.
• Present data cross-functionally in a matrixed team.

Skills

Stability studies design & execution

Cross-functional collaboration

Documentation & EDC usage

Data presentation & communication

Education

Masters degree

Bachelors degree + 2 years of scientific experience

Associates degree + 4 years of scientific experience

High school diploma / GED + 6 years of scientific experience

Tools

HPLC/UPLC

2-D HPLC methods

Mass spectrometry

Capillary electrophoresis

DSF

Light scattering

Tableau/Spotfire

JMP

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

• 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 organizations 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

Basic Qualifications

• Masters degree
• OR
• Bachelors 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

• Masters 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, well 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.

• 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.

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.