Career CategoryEngineering
Job DescriptionSr Engineer What you will doLet'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 youWe 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 ExperienceOR
Bachelor's degree and 4 years of
Engineering ExperienceOR
Associate's degree and 8 years of
Engineering ExperienceOR
High school diploma / GED and 10 years of
Engineering ExperiencePreferred 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 usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
