Process Development Sr Scientist

Amgen • Thousand Oaks, CA

3d

About The Position

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.

Requirements

• Bachelor’s degree and 5 years of Scientific experience OR Master’s degree and 3 years of Scientific experience OR Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

Nice To Haves

• Doctorate Degree (PhD OR PharmD) 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 instrumentation platforms and client-server data management systems
• Experience applying statistical analysis and data visualization tools
• Problem solver with a proactive demeanor and ability to collaborate and work in a cross functional/multidisciplinary environment
• Ability to take initiative, work independently, and be flexible in responsibilities
• Excellent written, verbal, and presentation skills – ability to distill, craft and present key messages relative to diverse audience requirements

Responsibilities

• Evaluation of drug candidate stability, structural elucidation, and identification of degradation pathways.
• Synthetics molecule assessment (developability 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees