Process Development Sr Scientist

Process Development Sr Scientist page is loaded## Process Development Sr Scientist remote type:
On Site locations:
US - California - Thousand Oakstime type:
Full time posted on:
Posted 30+ Days Agojob requisition :
R-228066##
** Career Category
** Scientific## ##
** 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. 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 Sr Scientist
**** What you will do
** Let’s do this! Let’s change the world!

In this dynamic role you will join the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team and support early formulation development and physicochemical characterization with a focus on chemical stability to advance preclinical and clinical development programs. In doing so you will contribute to regulatory filings and to Amgen’s intellectual property. In addition, you will have the opportunity to support activities and represent SET on both Discovery Research and Early Development teams, providing functional area expertise.
*
* Key Responsibilities include:

*** Evaluation of drug candidate stability, structural elucidation, and identification of degradation pathways.
* Synthetics molecule assessment (develop ability assessment) and preclinical formulation support
* Supporting lead optimization and form selection to meet the target product profile
* Application of in silico and in vitro models to support molecule and biopharmaceutical assessments and identify development strategies
* Coordinate with team members and external partners to meet defined tasks and project milestones
* Support the project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
* Apply continuous improvement practices to enhance overall laboratory efficiency
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative individual with these qualifications.
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* Basic Qualifications:

*** Bachelor’s degree and 5 years of Scientific experience OR
* Master’s degree and 3 years of Scientific experience OR
* Doctorate degree PhD OR Pharm

D OR MD [and relevant post-doc where applicable]
*
* Preferred Qualifications:

*** Doctorate Degree (PhD OR Pharm

D) with 2+ years of post-PhD experience in Pharmaceutics, Pharmacy, Chemistry or related field preferred
* Experience in synthetic, mechanistic, or physical organic chemistry, and structural elucidation is informed by knowledge of organic chemistry
* Strong understanding in Mass Spectrometry or Liquid Chromatography Mass Spectrometry (LCMS)
* Experience in preformulation techniques including HPLC analysis, physicochemical evaluation (solubility, stability, pKa and LogP determination, etc.) and solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) is beneficial
* Experience in chemical kinetics, pharmacokinetics or biopharmaceutical modeling is beneficial.
* Ability to take initiative, work independently, and be flexible in responsibilities
* Experience in liquid dosage forms (e.g. drug-in-bottle, parenteral, inhalation, topical) for synthetics
* An ability to integrate automation solutions and data science approaches to enhance laboratory workflows
* Proficiency with…