Lipid Chemistry Scientist - Scale-Up & Purification

Duration: 18 Months

Job description:
Summary:
The Organic Chemist / Scientist will play a critical role in the Fatty Acid project by developing, optimizing, scaling, and documenting synthetic and purification processes for priority lipid and fatty-acid-related raw materials used to support cell-culture media production. The role will focus initially on fatty acids and lipids and fatty acids and lipids, with potential expansion to other priority materials. The scientist will apply strong multi-step organic synthesis, lipid chemistry, purification, and analytical characterization skills to establish robust processes that meet internal raw-material specifications and are suitable for scale-up and transfer to manufacturing.

Key Responsibilities:

• Design, plan, and independently execute laboratory experiments for synthesis and process development of fatty acids, glycerides, phospholipids, and related lipid molecules.
• Develop and optimize synthetic routes for priority materials, including fatty acids and lipids, with emphasis on yield, purity, reproducibility, scalability, and raw-material availability.
• Develop and optimize purification strategies for intermediates and final products using normal-phase and reverse-phase chromatography, preparative HPLC/flash chromatography, crystallization, extraction, precipitation, and other appropriate techniques.
• Characterize starting materials, intermediates, impurities, and final products using HPLC, LC-MS/MS or MS, NMR, FT-IR, UV/VIS, ELSD/CAD, and other applicable analytical techniques.
• Investigate impurity profiles and troubleshoot synthesis, purification, stability, and recovery issues that could prevent materials from meeting internal specifications.
• Perform feasibility studies using lower-purity or alternate-source starting materials and define process conditions required to achieve target product quality.
• Support scale-up from laboratory development to gram/hundreds-of-gram scale and develop processes suitable for transfer to Rockford manufacturing operations.
• Partner with Analytical Development to establish or refine purity and identity methods and ensure analytical methods are fit for process-development decisions.
• Support preparation of material for internal evaluation, packaging/formulation activities, process validation, and manufacturing transfer as required by the project.
• Write experimental protocols, development reports, batch/process instructions, technical summaries, and documentation supporting testing, validation, and production.
• Maintain complete and accurate laboratory records and ensure traceability of experimental conditions, calculations, raw data, observations, deviations, and conclusions.
• Work cross-functionally with R&D, Analytical, Operations, Quality, Procurement/Sourcing, and project-management teams; communicate technical results, risks, recommendations, and project status to stakeholders.
• Adhere to departmental quality systems, chemical hygiene, EHS requirements, and safe laboratory practices.

Minimum Requirements / Qualifications:

• M.S. or Ph.D. in Organic Chemistry, Medicinal Chemistry, Chemical Sciences, or a closely related scientific discipline; Bachelor's degree with substantial directly relevant industrial synthetic chemistry experience may also be considered.
• Strong hands-on experience in organic synthesis, reaction optimization, and multi-step synthesis.
• Demonstrated experience with purification of complex organic molecules using chromatography and other preparative purification techniques.
• Hands-on experience interpreting HPLC, LC-MS/MS or MS, NMR, and FT-IR data for reaction monitoring, identity confirmation, purity assessment, and impurity troubleshooting.
• Ability to independently troubleshoot reactions and purification processes and design efficient experiments to resolve technical problems.
• Experience documenting experimental work in a manner suitable for process development, technology transfer, and regulated or quality-controlled environments.
• Ability to work independently while contributing effectively in a cross-functional project team.
• Excellent written, verbal, data-presentation, and technical communication skills.

Preferred Qualifications:

• Industrial experience with lipid chemistry, fatty-acid chemistry, glycerides, phospholipids, surfactants, or detergent-like molecules.
• Experience with synthesis or purification of phosphatidylcholines, diacylglycerols, or structurally related lipid molecules.
• Hands-on experience with Biotage Isolera/Selekt or comparable flash/preparative chromatography systems.
• Experience with CAD or ELSD detection for lipid/non-chromophoric compound analysis.
• Experience scaling synthetic chemistry processes from small-scale feasibility experiments to gram or hundreds-of-gram quantities.
• Experience in reagent/raw-material product development, process validation, change control, or transfer of R&D processes to manufacturing.
• Working knowledge of raw-material specifications, supplier qualification, and technical evaluation of alternate-source materials.

Success Measures:

• Development milestones completed according to the project plan.
• Target materials consistently meet required identity and purity specifications.
• Processes demonstrate acceptable yield, reproducibility, scalability, and operational practicality.
• Technical risks and deviations are identified early, investigated scientifically, and communicated with clear mitigation plans.
• Complete development documentation supports successful transfer to Operations and subsequent qualification/validation activities.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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