Process Development Scientist

Amgen • Cambridge, MA

1d • $111,941 - $151,449 • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

What you will do
Let’s do this. Let’s change the world. In this vital role you will join Amgen’s Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Cambridge, MA, is seeking a highly motivated and team-oriented individual for the position of Process Development Scientist. SET is a key Drug Product Technology interface with partners in Process Development and Research & Discovery. This individual will provide solid state characterization, with a strong focus on solid state NMR (ssNMR) spectroscopy, for drug substance and drug product process development for synthetics and biologics programs in support of SET’s key responsibilities which include:
•Utilize advanced solid-state characterization methods (e.g. ssNMR) to support drug substance and drug product process development for synthetics and biologics programs.
•Drive lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).
•Perform synthetics molecule assessment (developability assessment) and preclinical formulation support.
•Perform biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.
•Provide early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).
This individual will carry out solid-state analysis and physicochemical characterization to aid solid form and formulation development of drug substances and drug products. The primary responsibilities will include developing, implementing, and applying advanced ssNMR techniques to characterize the structures and interactions of small and large drug molecules. The role will leverage these techniques to investigate and resolve complex scientific questions in pharmaceutical materials science.

Requirements

• Doctorate degree
• Master’s degree and 2 years of Scientific experience
• Bachelor’s degree and 4 years of Scientific experience

Nice To Haves

• Master’s degree in one of the following areas: Physics, Materials Science, Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline
• Strong background in ssNMR spectroscopy method development and theory with a record of scientific presentations, such as, peer-reviewed publications
• Experience in ssNMR instrumentation, operation, and maintenance is beneficial
• Specific experience developing ssNMR methods to characterize small and large molecule drug substances and drug products, such as solid form analysis, impurity phase/amorphous content detection and physical stability assessment
• Experience in solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) is desired
• Working knowledge of solid form development such as polymorphism, solvates/hydrates and salt/co-crystal characterization is beneficial
• Good informatics skills and experience with molecular modelling calculations to study molecular interactions and simulate NMR experimental observables is beneficial
• Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements
• Problem solver with a proactive attitude and ability to collaborate and work in a cross-functional and multidisciplinary environment
• Abilities to take initiatives, work independently, and be flexible in responsibilities

Responsibilities

• Explore and implement ssNMR techniques to enhance productivity, robustness and efficiency of small molecules and biologics development.
• Take a proactive role in developing and applying innovative ssNMR approaches, demonstrating creativity in solving complex technical problems, for example understanding excipient-drug interactions and quantitative analysis of heterogeneous mixtures.
• Provide solid state characterization support to biopharmaceutics assessment, form screening/selection, and drug substance and drug product process development for synthetics and biologics programs.
• Interface with partners in Process Development and Research and Development.
• Support departmental activities including training staff and presenting scientific results at internal/external meetings.
• Build and maintain strong working relationships with key stakeholders internally and externally.
• Contributes to regulatory filings including IND and NDA as needed and assists in answering questions from regulatory authorities.
• Contributes to Amgen’s intellectual property and patent filings

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 where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree