Hiring For Preparative HPLC Purification Leader - AR&D

SAI Life Sciences; Hyderabad; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

SAI Life Sciences is seeking a seasoned Preparative HPLC Purification expert with over 20 years of hands-on and leadership experience in purifying complex biotech and pharmaceutical molecules.

The role covers development, optimization, scaling, and technology transfer from lab to plant-scale, with GMP manufacturing support and process validation involvement.

Qualifications

• 20+ years in preparative HPLC purification, process development, scale-up, and manufacturing support.
• Experience with purification of peptides, ADCs, linkers, oligonucleotides, GalNAcs and small molecules.

Responsibilities

• Lead preparative HPLC purification activities for diverse molecules and impurities.
• Develop, optimize, and troubleshoot purification methods for purity, yield, and throughput.
• Scale up purification from analytical to plant-scale operations.
• Drive technology transfer from R&D to manufacturing with readiness and reproducibility.
• Support process validation batches at plant scale with deviation investigations and data review.
• Provide guidance on impurity isolation, fraction strategy, column choice, loading optimization, and gradient design.
• Collaborate with cross-functional teams to ensure successful project delivery.
• Ensure GMP compliance, safety, data integrity, and proper documentation.
• Establish SOPs, training modules, and technical standards.
• Mentor a team of 10–15 scientists and staff.

Skills

Preparative HPLC

Method development

Scale-up

Technology transfer

GMP manufacturing

Education

Master's degree or PhD in Chemistry/Pharmaceutical Sciences/ Chemical Engineering/ Analytical Chemistry

Tools

Preparative HPLC systems

Chromatography data systems

Job description

Role Summary

We are seeking an accomplished Preparative HPLC Purification expert with more than 20 years of hands‑on and leadership experience in the purification of complex pharmaceutical and biotechnology molecules. The role requires deep technical expertise in developing, optimizing, scaling up, and transferring purification processes from laboratory scale to plant scale, with strong exposure to process validation support and GMP manufacturing environments.

Key Responsibilities

• Lead preparative HPLC purification activities for peptides, ADCs, linkers, oligonucleotides, GalNAcs, small molecules, intermediates, and process‑related impurities.
• Develop, optimize, and troubleshoot purification methods to improve purity, yield, recovery, throughput, robustness, and solvent efficiency.
• Scale up chromatographic purification processes from analytical and laboratory‑scale systems to pilot, kilo‑lab, and plant‑scale operations.
• Drive technology transfer of purification processes from R&D to manufacturing, ensuring technical readiness, documentation quality, and process reproducibility.
• Support process validation batches at plant scale, including execution readiness, deviation investigation, data review, and technical troubleshooting.
• Provide scientific guidance for impurity isolation, characterization support, fraction strategy, column selection, loading optimization, gradient design, buffer selection, and purification workflow improvement.
• Collaborate with process chemistry, analytical development, quality assurance, manufacturing, engineering, regulatory, and project management teams to ensure successful project delivery.
• Ensure compliance with GMP, safety, data integrity, documentation, and applicable regulatory expectations.
• Establish best practices, standard operating procedures, training modules, and technical standards for preparative purification operations.
• Mentor, coach, and manage a team of approximately 1015 scientists, chemists, and technical staff, ensuring capability building, productivity, and high‑quality execution.

Required Qualifications and Experience

• Masters degree or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Analytical Chemistry, Organic Chemistry, or a related discipline.
• Minimum 20 years of relevant experience in preparative HPLC purification, process development, scale‑up, and manufacturing support.
• Extensive experience with purification of peptides, GalNAcs, ADC‑related molecules, linkers, oligonucleotides, small molecules, and impurities.
• Strong understanding of reverse‑phase chromatography, ion‑pair chromatography, normal‑phase chromatography, chiral separations, ion‑exchange approaches, and related preparative purification techniques.
• Hands‑on experience with preparative HPLC systems, columns, detectors, fraction collectors, solvent systems, and chromatography data systems.
• Proven experience in transferring purification technologies from laboratory development to plant‑scale manufacturing.
• Demonstrated experience supporting process validation, GMP campaigns, technical investigations, and manufacturing troubleshooting.
• Strong knowledge of process robustness, column loading studies, impurity purge strategy, recovery optimization, and purification economics.
• Experience leading multidisciplinary technical teams and managing 10-15 team members in a development or manufacturing support environment.

Technical Competencies

• Preparative HPLC method development, optimization, troubleshooting, and scale‑up.
• Purification strategy design for complex synthetic and bioconjugated molecules.
• Technology transfer, process validation support, and GMP manufacturing readiness.
• Impurity isolation, fraction pooling strategy, solvent selection, and recovery improvement.
• Column chemistry selection, lifecycle management, cleaning strategy, and system suitability evaluation.
• Preparation and review of technical reports, batch records, validation protocols, deviation responses, and regulatory‑support documents.

Leadership Expectations

• Build and lead a high‑performing purification team with clear accountability, technical depth, and strong execution discipline.
• Prioritize project work, allocate resources, review technical risks, and ensure timely delivery of purification milestones.
• Develop junior and mid‑level scientists through coaching, technical review, and structured training.
• Promote a culture of safety, compliance, scientific rigor, collaboration, and continuous improvement.
• Represent purification function in cross‑functional project meetings, technology transfer discussions, manufacturing readiness reviews, and process validation forums.

Preferred Attributes

• Strong problem‑solving ability for difficult separations, low recovery, poor resolution, high solvent consumption, and scale‑up challenges.
• Ability to balance scientific quality, plant feasibility, timelines, cost, and regulatory expectations.
• Excellent communication, technical writing, stakeholder management, and decision‑making skills.
• Experience working with global teams, external partners, contract manufacturing organizations, or customer‑facing technical programs is desirable.