Process Development Associate

Amgen SA; Cambridge (MA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Process Development Associate to contribute to Drug Substance Process Development for late stage biologics. You will work across cell culture and purification areas, designing bench-scale experiments to advance upstream and downstream operations and supporting technology transfer to manufacturing.

You will collaborate in a diverse team, using in-house analytics and visualization tools, to improve process yield and robustness while developing expertise in both cell culture and

Qualifications

• Basic qualifications include a Bachelor’s/Associate/High School path with scientific experience.
• Experience with mammalian cell culture and/or purification operations is preferred.
• Knowledge of cell culture, protein chromatography, and filtration principles is desirable.

Responsibilities

• Contribute within a project team to improve yield and robustness and scale-up processes.
• Perform small-scale bioprocess experiments covering upstream and downstream operations.
• Maintain cultures in shake flasks, bags, and benchtop bioreactors; execute purification experiments.
• Assist with automation for benchtop bioreactors and chromatography systems; support data analysis.
• Prepare technical reports and GMP documentation for regulatory filings; communicate findings.

Skills

Cell culture

Protein chromatography

Filtration principles

Design of experiments

Statistical analysis

Communication skills

Team collaboration

Education

Bachelor’s or higher in Chemical/Biomedical Engineering or Life Sciences

Associate’s degree with 2 years of scientific experience

High school diploma with 4 years of scientific experience

Tools

Bioreactors

Chromatography systems

UF/DF filtration

DOE software

Job description

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

What you will do

Let’s do this. Let’s change the world. In this vital role you will contribute towards Amgen’s Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application. This role is within an integrated organization in which cell culture and purification scientists work together to advance Amgen's rich and dynamic pipeline. With Amgen's biology first approach, the position provides a unique opportunity to work on multiple modalities, from antibodies to oncolytic viruses to bi-specifics.

The Process Development Associate will help design and perform experiments at the bench scale that span the end-to-end Drug Substance process, from cell culture to purification operations. In this role, you will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the Process Development Associate will utilize out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in both cell culture and purification, thereby further contributing to the integrated group. The Process Development Associate will join a diverse team with varied levels of experience and report to a Process Development Principal Scientist.

• Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites
• Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
• Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
• Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations
• Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems
• Experimental design and data interpretation, leveraging in-house visualization and analytics tools
• Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
• Provide scientific technical support for technology transfer of processes to manufacturing sites

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:

• Bachelor’s Degree
• Associate’s degree and 2 years of Scientific experience
• High school diploma/GED and 4 years of Scientific experience

Preferred Qualifications:

• Bachelor's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
• Experience and demonstrated interest in laboratory work, particularly hands-on experience with mammalian cell culture and/or purification operations
• Basic understanding of cell culture, protein chromatography, and filtration principles
• Demonstrated ability to identify and solve problems by applying scientific and engineering principles, preferably in a process development environment
• Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members
• Familiarity with design of experiments and statistical analysis of data

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.

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.

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.