Program Development Associate Jobs in Simi Valley, CA

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 Senior Associate

Let's do this. Let's change the world. In this vital role you will join the Pivotal Drug Product Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio.

Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and lifecycle management.

Responsibilities:

• 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

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

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

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
• 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)

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.

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 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 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.

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.

Salary Range