Sr. Engineer, Process Development

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 115,000 - 156,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement plan

Flexible work models

Job summary

Amgen Inc. in Thousand Oaks is seeking a Senior Engineer to author technical reports, lead risk assessments, and contribute to regulatory documents during technology transfer and scale-up for synthetic and hybrid processes.

You will design, optimize, and deploy process models, evaluate novel chemical processes, and provide on-the-floor support to ensure successful scale-up and rapid problem solving within a collaborative, cross-functional team.

Qualifications

• Doctorate degree OR Master’s degree with relevant experience in engineering.
• Experience with technology transfer, scale-up and manufacturing in regulated environments.
• Familiar with regulatory documents for drug substance processes (CMC).

Responsibilities

• Author technical reports, lead risk assessments, and contribute to regulatory documents.
• Design and optimize process models for kinetics, mass transfer and separations.
• Support tech transfer activities and scale-up for manufacturing concepts.
• Collaborate with chemists and analytical scientists to interpret data and guide scale-up.

Skills

Process modeling

Tech transfer

Process scale-up

Regulatory knowledge

Statistical analysis

Communication skills

Laboratory operations

Risk assessment

Education

PhD in Chemical Engineering

MS in Chemical Engineering

Bachelor's degree in Engineering

Tools

HPLC

GC

MS

NMR

Job description

Career Category Engineering 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.

Sr Engineer

What you will do

Let’s do this. Let’s change the world.

• In this vital role you will be responsible for authoring technical reports, leading risk assessments, and contributing to regulatory documents through all phases of technology transfer and commercialization.
• Position located in either Cambridge, MA or Thousand Oaks, CA.
• Domestic and International Travel: up to 20%.
• Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes.
• Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements necessary to ensure safe and successful scale-up and tech transfer.
• Design, optimize, and deploy process models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
• Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts.
• Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.
• Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline, such that key milestones are established and achieved.
• Apply standard and advanced engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
• Routinely monitor manufacturing processes for performance indicators and operations.
• Lead problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.
• Author, review and/or approve of process documentation needed for process validation and commercialization activities.
• Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.
• Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making.
• Lead or represent department as subject matter expert for process risk analysis.
• Work closely with process development chemists, formulation scientists, and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.

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

• Doctorate degree OR Master’s degree and 2 years of Engineering Experience OR Bachelor’s degree and 4 years of Engineering Experience OR Associate’s degree and 8 years of Engineering Experience OR High school diploma / GED and 10 years of Engineering Experience

Preferred Qualifications

• Familiar with bioprocessing unit operations required to support ADCs and/or oligonucleotides, including conjugation and purification.
• Experience in developing and executing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, and productivity.
• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.
• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.
• Experience building and utilizing first-principles models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.
• Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
• Experience using data science and/or advanced statistical analysis to solve processing issues and evaluate opportunities for process improvements.
• Proficient understanding of regulatory and cGMP requirements.
• Command of lab and plant operations and associated safety practices.
• Familiarity with HPAPI processing and containment.
• Engineering knowledge around linker payload chemistry and scale-up.
• Strong communication and presentation skills

What you can expect from 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.

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.

Equal Opportunity

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.

Salary Range

Salary Range 115,494.60USD -156,257.40 USD

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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen