Senior Engineer - Process Development
Location: Cambridge
Posted on: June 23, 2025
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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. Senior Engineer - Process Development
What you will do Lets do this. Lets change the world. In this vital
role you will be accountable to advance industry leading solutions
for the design, development, and deployment of synthetic and hybrid
drug substance manufacturing processes across all phases of
development through commercialization. The qualified candidate will
be proficient in chemical engineering fundamentals, process
development & characterization, and process safety & scale-up for
synthetic processes using both batch and continuous technologies.
The Senior Engineer will provide technical leadership for reaction
engineering, unit operation assessment, and technology development
& implementation. The Senior Engineer will partner with or lead a
multi-functional group of engineers and scientists through the
process development cycle at Amgen to ensure our process
requirements and knowledge are suitable for the intended phase of
technology transfer, which will include process introduction,
clinical manufacturing, validation and commercial manufacturing.
While working with our manufacturing teams to determine if
equipment and manufacturing operations meet process requirements
and will collaborate with the production site(s) to introduce new
equipment and capabilities. The Senior Engineer will be responsible
for authoring technical reports, leading risk assessments, and
contributing to regulatory documents through all phases of
technology transfer and commercialization. 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 vital 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 achievements are established and achieved.
Apply standard and sophisticated 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 vital
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 domain 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 Engineering
professional we seek is an individual with these qualifications.
Basic Qualifications: High school diploma / GED and 10 years of
Engineering experience; OR Associates degree and 8 years of
Engineering experience; Or Bachelors degree and 4 years of
Engineering experience; Or Masters degree and 2 years of
Engineering experience; Or Doctorate degree Preferred
Qualifications: 5 years of engineering experience getting results
related to synthetic process development and chemical
manufacturing. Experience in developing and implementing
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 applying
first-principle 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
proficiency 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 sophisticated statistical
analysis to address 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 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, 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 and make a lasting impact
with the Amgen team. careers.amgen.com 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.
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 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.
Keywords: , Attleboro , Senior Engineer - Process Development, Engineering , Cambridge, Massachusetts
