Research Scientist (Crystallization R&D )

Porton Pharma Solutions Ltd.; Cranbury Township (NJ); On-site; USD 85,000 - 120,000; Full time

Job summary

Porton Pharma Solutions Ltd. is seeking a Research Scientist to lead crystallization R&D, focusing on solid form screening, development of crystallization processes, and formulation support for preclinical studies.

The role emphasizes analytical characterization, phase mapping, and process optimization within a cGMP environment. The successful candidate will work in Cranbury NJ onsite, collaborating with cross-functional teams to deliver robust solid-state solutions for drug substances and

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 crystallization process development.
• Good understanding of solid-state chemistry of small molecule drug substances.
• Working knowledge of PXRD, TGA, DSC, PLM, DVS, HPLC, NMR and PSD.
• Experience in the pharmaceutical/biotechnology industry or CDMO industry is required. Experience in both is desirable but not required.

Responsibilities

• Lead solid form screening & characterization including PXRD, DSC, TGA, SEM, particle size, PLM, moisture sorption analysis, solubility, dissolution and stability assessments.
• Understand solid form phase mapping to assist crystallization process development.
• Carry out 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.
• Learn continuously and apply fundamentals of instrumentation knowledge (automation, PAT), and simulation tools in crystallization process development.
• Implement new technologies and ways of working to enhance technical rigor and efficiency.
• Contribute weekly client updates and final reports on timelines.
• 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 development, calibration, and maintenance of laboratory instruments and equipment.

Skills

PXRD

DSC

TGA

PLM

HPLC

NMR

Solid-state chemistry

Formulation development

Data analysis

Education

MS or BS in Chemistry/Pharmaceutical Sciences/Engineering

Tools

cGMP procedures

Job description

Job Title: Research Scientist of Crystallization R&D

Department: Crystallization R&D

Location: Onsite, Cranbury NJ

Job Type: Full Time

Position Reports to: Head 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 search for the right solid form and develop formulations to support preclinical studies including PK, PD, efficacy, tox studies. This role is also responsible for crystallization process development, with goals of controlling 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:

• 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.
• Learn continuously and apply fundamentals of related instrumentation knowledge (automation, PAT), and simulation tools in effective crystallization process development, from experimental design to operation, data collection, result analysis and presentation.
• 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).
• Perform other relevant duties as assigned by the management team.

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.