Process Development Senior Scientist

Amgen Inc. (IR); Cambridge (MA); On-site; USD 126,000 - 171,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Stock-based long-term incentives

Flexible work models

Job summary

Amgen Inc. is seeking a Process Development Senior Scientist in Cambridge, MA, to develop, characterize, and scale-up drug substance processes for late-stage programs.

You will collaborate with cell culture and purification teams to advance biologics pipelines and ensure robust, compliant manufacturing processes. The role requires advanced degrees with strong purification expertise, experience in cGMP environments, and leadership in cross-functional settings across analytical and regulatory

Qualifications

• Doctorate or Master7s with 2+ years Life Sciences experience OR Bachelor7s with 4+ years Life Sciences experience
• PhD in Chemical Engineering, Biochemical Engineering or related fields preferred
• Proven track record in protein purification process development
• Experience with cGMP manufacturing and regulatory submissions will be advantageous

Responsibilities

• Develop, characterize, scale-up and support drug substance processes for late-stage programs
• Work with cell culture and purification scientists to advance biologics pipelines
• Apply platform approaches and problem-solving to tackle drug substance challenges
• Collaborate cross-functionally with analytical and drug product teams to deliver manufacturing processes

Skills

Protein chromatography

Filtration operations

Problem-solving

Leadership

Cross-functional collaboration

Education

Doctorate degree

Master's degree in Life Sciences

Bachelor's degree in Life Sciences

Tools

Design of Experiments (DOE)

Job description

Career Category Operations 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 Senior Scientist

What you will do

Let's do this. Let's change the world. In this vital role you will be responsible for development, characterization, scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and dynamic pipeline. With Amgen's biology first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs. The Pivotal Drug Substance Process Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across the Amgen portfolio. Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation Drive innovation and utilize out-of-the-box thinking to contribute to technology development Expand and develop skills in purification and cell culture, thereby further contributing to the integrated group Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner. Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing

What we expect of you

• Basic Qualifications: Doctorate degree OR Master's degree and 2 years of Life Sciences experience OR Bachelor's degree and 4 years of Life Sciences experience
• Preferred Qualifications: Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
• Consistent track record of decision-making and trouble-shooting protein drug substance purification processes, preferably in a process development environment
• Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography
• Experience in filtration operations, including ultrafiltration/diafiltration
• Understanding of protein characteristics and critical attributes to direct product/process control strategies
• Proven ability to independently identify, develop and implement scientific solutions to practical problems.
• Motivated self-starter with excellent interpersonal and organizational skills
• Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists
• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications
• Demonstrated success working with diverse team members in a dynamic, cross-functional environment
• Familiarity with design of experiments and statistical analysis of data
• Knowledge of license applications and the drug development process
• Exposure to cGMP manufacturing and CMC components of regulatory submissions

What you can expect from us

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

Salary Range 126,066.05USD -170,559.95 USD

Sponsorship for this role is not guaranteed.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.