SPI Pharma: Research Scientist

SPI Pharma, a part of Associated British Foods plc, is a trusted global leader in providing innovative solutions to the pharmaceutical and nutraceutical industries. With decades of expertise, SPI Pharma specializes in the development and supply of high-quality excipients, antacid actives, drug delivery systems, and taste-masked technologies.

Our products help pharmaceutical companies create better-tasting, patient-friendly, and more effective oral dosage forms, including tablets, capsules, soft gels, and liquid suspensions. We support our customers from concept to commercialization through our advanced technical services, dedicated R&D teams, and a strong commitment to quality and compliance.

At SPI Pharma, we value scientific excellence, collaboration, and innovation to deliver meaningful healthcare solutions worldwide.

We are looking for a skilled and motivated Research Scientist – Analytical Development to join our R&D team. The ideal candidate will have a solid background in pharmaceutical sciences or chemistry, with strong hands-on experience in analytical method development, validation, and routine testing of pharmaceutical dosage forms — especially soft gelatin capsules and solid orals.

The role requires excellent technical knowledge of key analytical instruments, good documentation skills, regulatory awareness, and the ability to work independently and in cross-functional teams.

• Execute all laboratory activities safely and reliably, strictly adhering to Pharmaceutical GLP/GMP guidelines and internal SOPs.

• Develop, validate, and implement robust analytical methods for drug substances, reference standards (RS), impurities, and finished dosage forms.

• Perform routine analytical testing such as Assay, Dissolution, Related Substances, Content Uniformity, and other quality tests with a special focus on soft gelatin capsules and other solid orals.

• Conduct analytical testing for formulations under stability studies as per ICH guidelines.

• Independently troubleshoot analytical or instrumental issues and recommend effective solutions in a timely manner.

• Ensure proper calibration and maintenance of analytical instruments such as HPLC, UPLC, UV-Vis Spectrophotometer, FTIR, DSC/TGA, Dissolution Apparatus, KF Titrator, Rheometer, etc.

• Maintain accurate and up-to-date lab notebooks, raw data, and reports in line with Good Documentation Practices (GDP).

• Prepare comprehensive method development and validation reports, technical presentations, and, where appropriate, support the publication of technical data in reputable journals.

• Support regulatory submissions by providing necessary analytical data and documentation.

• Collaborate closely with cross-functional teams including formulation R&D, quality control, manufacturing, regulatory affairs, and external partners.

• Travel to other company locations, customer sites, or contract manufacturing organizations (CMOs) for method transfer, troubleshooting, or technical support as required.

• Meet project priorities, timelines, and deliverables while maintaining high standards of quality and compliance.

Education:

• Master's degree in Pharmaceutical Sciences (M.Pharm) or M.Sc. in Chemistry.

• B.Pharm acceptable for junior roles (optional).

Technical Expertise:

• Strong knowledge and practical experience in analytical method development and validation.

• Proficiency in operating and troubleshooting instruments like HPLC, UPLC, GC-MS, LC-MS/MS, ICP-MS, UV-Vis, FTIR, XRPD/XRD, DSC, TGA, Dissolution Apparatus, KF Titrator, and other relevant tools.

• Sound understanding of pre-formulation and stability study protocols.

• Experience in handling soft gelatin capsules and various dosage forms like tablets, capsules, ODTs, ER, DR, etc., is an added advantage.

• Familiarity with ICH guidelines, FDA/EMA requirements, and GLP/GMP compliance.

Soft Skills:

• Proactive and solution-oriented mindset for addressing analytical challenges.

• Strong documentation and report-writing skills.

• Effective verbal and written communication.

• Ability to work both independently and within a cross-functional team.

• Organized, detail-oriented, and committed to timelines and quality standards.