Process Development Sr Associate - Drug Product Technologies

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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. 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 Sr Associate - Drug Product Technologies

What you will do

Lets do this! Lets change the world!

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), fusion proteins, etc.). The Senior Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management.

Responsibilities include:

• Utilize high throughput technologies and automation platforms in the execution of formulation and process development studies.

• Identify and implement innovative solutions to increase throughput, improve quality, and streamline data capture and analysis.

• Participate in the planning, design, and execution of formulation and process development studies by applying basic science/engineering skills and prior knowledge.

• Evaluate product and process performance through analytical testing (e.g., U/HPLC, particle analysis, moisture content, physical properties, etc.) and perform subsequent data analysis and method compliance assessments as appropriate.

• Demonstrate technical writing and data integrity in authoring and data verifying technical protocols and reports, electronic laboratory notebooks, and regulatory documents.

• 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 dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 6 years of Scientific, Engineering, or Operations experience OR

• Associates degree and 4 years of Scientific, Engineering, or Operations experience OR

• Bachelors degree and 2 years of Scientific, Engineering, or Operations experience OR

• Masters degree

Preferred Qualifications:

• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related subject area.

• 1+ years of experience in pharmaceuticals/biotechnology that includes high throughput methodologies, process characterization, formulation development, and equipment implementation.

• Familiar and proficient in operating high throughput technologies (e.g., plate-based liquid handling, and analytical testing) and workflow execution, as well as the subsequent analysis of resulting data.

• Familiarity with pharmaceutical/biotechnology process development. Knowledge of Drug Product unit operations and experience with relevant analytical techniques.

• Understanding of physical/chemical stability of proteins and how formulation and process-related stresses impact molecule attributes and product quality.

• Proficiency in data analysis and processing.

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, and follow instructions, while aligning with guidance and compliance requirements.

• Demonstrated strong communication skills and ability to multi-task and work collaboratively in a cross-functional team environment.

• 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.

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.

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