Process Development Scientist

Within 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 spectroscopy, for drug substance and drug product process development for synthetics and biologics programs in support of SET's key responsibilities which include:

• Solid state characterization support for drug substance and drug product process development for synthetics and biologics programs.

• Enabling lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).

• Synthetics molecule assessment (developability assessment) and preclinical formulation support.

• Biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.

• 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 form and formulation development of drug substances and drug products. In particular, the primary responsibilities will dinclude the implementation, development and application of advanced ssNMR techniques to understand structures and interactions of small and large drug molecules as well as to address a wide range of challenging issues in pharmaceutical materials science.

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.
  
  Basic Qualifications:
  
  Doctorate degree or Doctorate degree completed by September 2019
  
  OR
  
  Master's degree & 4 years of scientific experience
  
  OR
  
  Bachelor's degree & 6 years of scientific experience
  
  Preferred Qualifications:

• Doctorate Degree in one of the following areas: Physics, Materials Science, Pharmaceutical Sciences, Chemical Engineering, Organic Chemistry, Physical Chemistry, Biochemistry, Protein Chemistry, or a related scientific discipline with 1+ years of post-doctoral or industry experience
• Strong background in ssNMR spectroscopy (instrumentation, operation, maintenance, method development and theory) is required with a successful track record of publications including peer-reviewed journals
• Solid experience in developing ssNMR methods to characterize small and large molecule drug substances and drug products, such as crystal form analysis, impurity phase/amorphous content detection and physical stability assessment
• Experience in solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, quantification, etc.), pre-formulation techniques including HPLC analysis, physicochemical evaluation (solubility, pKa and LogP determination, etc.)
• Working knowledge of crystal form development such as polymorphism, solvates/hydrates and salt/co-crystal characterization
• Good informatics skills and experience with molecular modelling calculations to study molecular interactions
• 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

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.