Job Description:

We are looking for an experienced and technically strong Team Leader - Analytical R&D to lead a team of analytical scientists supporting process and product development initiatives.

The role requires strong expertise in analytical method development, method validation, analytical technology transfer, chromatography, spectroscopy, and regulatory compliance.

The successful candidate will provide technical leadership to a team of 5 - 10 members, drive analytical project execution within defined timelines, and collaborate closely with Customers, Production Engineering, Quality Assurance, Regulatory Affairs, QC, and other cross-functional stakeholders.

The role offers an opportunity to contribute to complex analytical development programs while ensuring high standards of scientific quality, regulatory compliance, data integrity, safety, and operational excellence.

Key Responsibilities:

Analytical Method Development:

- Provide technical leadership for analytical method development activities supporting process and product development.

- Design appropriate experiments and analytical strategies based on project requirements and scientific objectives.

- Develop, optimize, and troubleshoot analytical methods for characterization, identification, purity, impurities, assay, degradation products, and related attributes.

- Evaluate analytical data and provide scientifically sound recommendations to project teams.

- Select appropriate analytical techniques based on molecule, formulation, process requirements, and method objectives.

- Support investigations related to analytical challenges, unexpected results, method performance, and process-related analytical requirements.

- Ensure analytical methods are robust, reproducible, scientifically justified, and suitable for their intended purpose.

- Review experimental designs, analytical data, interpretations, and technical conclusions generated by team members.

Project Planning & Execution:

- Lead and manage a team of 5 - 10 analytical R&D professionals.

- Plan analytical activities, timelines, deliverables, and resource requirements across multiple projects.

- Allocate resources effectively based on project priorities, technical requirements, and timelines.

- Monitor project progress and proactively identify risks, dependencies, bottlenecks, and potential delays.

- Ensure analytical deliverables are completed within agreed timelines with a target of >95% On-Time-In-Full (OTIF) delivery.

- Review and close ELN experiments and ensure appropriate documentation of analytical activities.

- Review analytical reports, technical documents, experimental results, and project deliverables.

- Drive continuous improvement in analytical workflows, productivity, documentation, and project execution.

- Ensure effective prioritization of activities in a dynamic, multi-project environment.

Analytical Method Validation:

- Lead the development and review of analytical method validation strategies.

- Prepare and review validation protocols, reports, and supporting technical documentation.

- Ensure validation activities comply with applicable regulatory expectations and internal procedures.

- Review validation results and assess method performance against predefined acceptance criteria.

- Identify and address deviations, failures, and unexpected results during validation activities.

- Provide technical guidance for investigations and corrective/preventive actions where required.

Analytical Method Transfer:

- Lead analytical method transfer activities from Analytical R&D to Quality Control (QC) laboratories.

- Ensure methods are appropriately documented and technically ready for transfer.

- Coordinate with QC teams to support successful implementation of analytical methods.

- Review transfer protocols, reports, results, and associated documentation.

- Troubleshoot method-transfer challenges and coordinate appropriate corrective actions.

- Drive a method-transfer success rate aligned with the target of <2% failure rate.

Chromatography & Spectroscopy:

- Provide advanced technical expertise in chromatographic techniques and their applications.

- Support method development and troubleshooting using appropriate chromatographic techniques.

- Demonstrate strong understanding of chromatographic method parameters, system suitability, selectivity, sensitivity, resolution, accuracy, and precision.

- Apply appropriate spectroscopic techniques for characterization and analytical investigations.

- Utilize knowledge of solid-state properties to support analytical characterization and product/process development.

- Evaluate analytical results from multiple techniques and provide meaningful scientific interpretation.

Cross-Functional Collaboration:

- Serve as the primary analytical point of contact for Customers, Production Engineers, QA, RA, QC, and other stakeholders.

- Understand project requirements and translate business and scientific needs into appropriate analytical strategies.

- Participate in cross-functional project meetings and provide technical recommendations.

- Communicate project status, analytical findings, technical risks, and recommendations effectively.

- Partner with Quality and Regulatory teams to ensure analytical activities meet applicable requirements.

- Support discussions related to analytical strategy, method readiness, technical feasibility, and project timelines.

Regulatory Compliance & Data Integrity:

- Ensure 100% compliance with applicable SOPs, GxP requirements, quality systems, and regulatory expectations.

- Ensure analytical activities are conducted in accordance with approved procedures and documented appropriately.

- Maintain high standards of data integrity, traceability, accuracy, and scientific documentation.

- Support internal and external audits and inspections as required.

- Lead the team through DQA audits and ensure timely closure of observations and action items.

- Ensure deviations, investigations, CAPAs, change controls, and other quality-related activities are appropriately addressed.

- Promote a strong quality culture across the analytical R&D team.

Safety:

- Promote and maintain a strong safety culture within the laboratory and analytical development environment.

- Ensure team members follow laboratory safety procedures, chemical handling requirements, and applicable EHS guidelines.

- Identify potential laboratory and operational hazards and implement appropriate preventive measures.

- Support the goal of maintaining a zero-incident safety environment.

- Ensure appropriate documentation and reporting of safety-related activities.

Team Leadership & Development:

- Lead, coach, mentor, and develop a team of analytical scientists.

- Provide technical guidance and support for complex analytical challenges.

- Review individual and team performance and provide constructive feedback.

- Identify training and development requirements for team members.

- Encourage knowledge sharing, scientific discussions, and continuous learning.

- Build a collaborative, accountable, and high-performing team environment.

- Support team members in developing their technical and project-management capabilities.

- Promote data-driven decision-making and scientific problem-solving.

RFP & Business Development Support:

- Provide technical inputs for RFP (Request for Proposal) evaluations.

- Review customer requirements and assess analytical feasibility.

- Contribute technical information, analytical strategies, timelines, and resource estimates for proposals.

- Collaborate with business development and technical teams to support new opportunities.

- Participate in customer discussions where analytical expertise is required.

Continuous Improvement:

- Identify opportunities to improve analytical methods, laboratory processes, workflows, and project execution.

- Stay updated on emerging analytical technologies, regulatory expectations, and industry best practices.

- Evaluate and implement innovative analytical approaches where appropriate.

- Encourage the use of data-driven approaches for scientific and business decisions.

- Drive improvements in analytical turnaround time, method robustness, transfer success, and project delivery.

Required Qualifications:

- M.Sc. with PhD in Organic Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a closely related discipline.

- 9+ years of relevant experience in Analytical R&D after PhD.

- Strong experience in analytical method development and characterization.

- Demonstrated experience leading analytical R&D teams.

- Experience managing multiple projects and delivering analytical activities within strict timelines.

- Experience working in regulated environments with strong knowledge of GxP requirements.

- Strong experience with analytical method validation and technology transfer.

- Experience working with cross-functional teams including QA, QC, RA, Production, Engineering, and Customers.