Process Development Sr Scientist Full-time NEW

Process Development Sr Scientist

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.

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 (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

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.

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 PharmD OR MD [and relevant post-doc where applicable]

Preferred Qualifications:

• 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

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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.