Job Description

Job Title: Research Scientist (Form Studies, Preformulation and Crystallization Process Development)

Department: Crystallization R&D

Location: Onsite, Cranbury NJ

Job Type: Full Time

Position Reports to: VP of Crystallization R&D

Job Summary:

We are seeking a highly motivated and skilled Research Scientist to join our Crystallization R&D Department at Porton J-STAR. In this role, this position is responsible for leading group or contributing individually to conduct Solid Form Studies and pre-formulation will search for the right solid form and develop formulations to support preclinical and Phase I studies including PK, PD, efficacy, tox studies. This role is also responsible for Crystallization Process Development will develop crystallization processes to define and control final solid form of drug substances with desired solid-state attributes needed for optimum performance as well as drug intermediates for robust purification. The responsibilities of the position include, but are not necessarily limited to, the items listed below.

Responsibilities

• Develop innovative technologies focused on improving the efficiency of laboratory crystallization and to provide greater depth of process understanding with the application of Process Analytical Technology (PAT) and process modeling.
• Carry out rational design and control of drug substance physical properties through particle engineering technologies and drug substance-drug product coprocessing.
• Perform activities in phase-appropriate solid form selection and physicochemical characterization, such as powder X-ray diffraction, DSC, TGA, SEM, particle size, polarized light microscopy, moisture sorption analysis, solubility, dissolution and stability assessments.
• Map polymorph, salt and cocrystal spaces of drug substances for selection of final solid form for development
• Understand solid form phase mapping of drug candidates to assist in crystallization process development
• Designs experiments, strategies and workflows to improve bioavailability of poorly soluble drug molecules through enabling technologies.

Lead or contribute to research and development of crystallization processes, solid form characterization, and pre-formulation studies for drug candidates.

Conduct particle engineering studies and develop strategies for improving crystal form stability, solubility, and bioavailability.

Investigate and apply new methodologies in crystallography and co-processing to optimize solid-state properties.

Coordinate and lead scientific and technical discussions with internal teams (e.g., project scientists, formulation scientists, analytical teams) and clients to plan, execute, and resolve project-related challenges.

Ensure effective communication across teams, maintaining clear and timely updates on project status and progress.

Coordinate weekly client updates and ensure that all team members provide timely progress reports.

Prepare and submit final technical reports and documentation to clients in accordance with project timelines.

Provide clear, candid, and professional communication with clients, peers, and management on project status, challenges, and outcomes.

Lead idea generation for proposals, quotes, and project plans, ensuring that proposed solutions align with client needs and project objectives.

Maintain a safe and clean laboratory environment, adhering to laboratory safety protocols and best practices.

• Contribute to the development, calibration, and maintenance of laboratory instruments and equipment to support crystallization and solid-state research.

Maintain accurate and detailed scientific records, including lab notebooks, experimental data, and process development documentation.

Ensure all documentation is compliant with Good Laboratory Practice (GLP) and regulatory requirements.

Perform other relevant duties as assigned by management, including supporting various R&D initiatives and participating in team-wide process improvements.

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 or chemical process development. (solution, suspension, tablet, capsule, etc).
• 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.

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