Process Development Senior Associate

BioSpace; Thousand Oaks (CA); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Retirement plan

Health/dental/vision insurance

Stock-based incentives

Discretionary annual bonus

Flexible work model

Job summary

Amgen in Thousand Oaks, CA, seeks a Process Development Senior Associate to join our Pivotal Drug Product Technologies group. You will support late-stage biologics formulation development and drug product commercialization, collaborating with engineers and scientists to advance process design and quality.

The role emphasizes analytical testing, data-driven decision making, and the use of advanced software to automate analyses and build intuitive visualizations.

Qualifications

• Master's degree or equivalent with scientific experience.
• Experience in pharmaceuticals/biotechnology process development or characterization.
• Familiarity with Drug Product unit operations and analytical techniques.

Responsibilities

• Plan and design formulation and process development studies.
• Execute and document lab studies with high accuracy.
• Evaluate product and process performance via analytical testing.
• Build data analytics using dashboarding tools.
• Perform data analysis with statistical software.
• Apply digital tools to automate data workflows and visualizations.
• Author/review technical protocols and reports.
• Participate in team meetings sharing results and challenges.

Skills

Statistical analysis

Programming (Python, R, MATLAB)

Data visualization (Tableau, Spotfire,

Education

Masters degree

Bachelors + 2 years scientific experience

Associates + 4 years scientific experience

High school diploma / GED + 6 years scientific experience

Tools

SAS

JMP

Minitab

Python

R

MATLAB

SQL

Tableau

Spotfire

D3js

Job description

Basic Qualifications
Masters degreeJoin 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 Senior Associate
What You Will Do
Lets do this. Lets change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgens Late-Stage biologics. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management.

• Participate in the planning and design of formulation and process development studies by applying basic science/engineering skills and prior knowledge
• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)
• Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)
• Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet
• Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
• Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
• Author/review technical protocols and reports
• Participate in team meetings by sharing study designs, results and technical challenges
  

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
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

• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related field
• 1+ years of experience in pharmaceuticals/biotechnology that includes process characterization, formulation development, equipment design and implementation, technology transfers
• Familiarity with pharmaceutical/biotechnology process development
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
• Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality. Familiarity with ADCs is preferred.
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies
• Self-motivation, adaptability and a positive attitude
• Critical thinking, problem solving and independent research skills
• Good organizational skills with strong attention to detail
• Excellent communication (oral and written)
  

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.
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.
  

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.Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.Sponsorship
Sponsorship for this role is not guaranteed.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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.