Research Scientist (Crystallization R&D )

Responsibilities

• Perform activities in phase-appropriate solid form screening & selection and solid-state characterization, such as powder X-ray diffraction, DSC, TGA, SEM, particle size, polarized light microscopy, moisture sorption analysis, solubility, dissolution and stability assessments.
• Understand solid form phase mapping of drug candidates to assist in crystallization process development.
• Carry out experiments in preformulation and developability assessment.
• Conduct phase-appropriate crystallization process development for API and intermediates to meet critical quality attributes.
• Carry out rational design and control of drug substance physical properties through particle engineering technologies and drug substance-drug product coprocessing.
• Implement new technologies, systems and ways of working to enhance both technical rigor and operational efficiency to better meet the demands of diverse drug developmental programs.
• Contribute weekly client updates, ensure weekly update and final reports submitted in a timely fashion.
• Prepare and submit final technical reports and documentation to clients in accordance with project timelines.
• Communicate candidly, clearly and timely with clients, management, peers and group members.
• Maintain a safe and clean laboratory environment, comply with cGMP procedures, and company policies.
• Contribute to the development, calibration, and maintenance of laboratory instruments and equipment to support crystallization and solid-state research.
• Maintain appropriate documentation (batch records and lab notebooks).

Qualifications

• MS or BS. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a focus on crystallization, solid-state chemistry, or materials science.
• 1-5 years of experience in solid form studies and preformulation development, crystallization process development.
• Good understanding of solid-state chemistry of small molecule drug substances.
• Working knowledge of analytical techniques such as PXRD, TGA, DSC, PLM, DVS, HPLC, NMR and PSD.
• Experience within the pharmaceutical/biotechnology industry or CDMO industry is required. Experience in both is desirable but not required.
• Proven track record meeting aggressive targets as related to safe, timely and successful projects.
• Good written, verbal and presentation skills.
• Strong communication, organization, and planning skills.
• Ability to prioritize and manage numerous activities simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.