Sai Life Sciences Limited

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Position: Head of Analytical R&D

Reporting to: Global Head of R&D

Location: Shamirpet, Hyderabad

Purpose of the role:

Responsible for defining and executing the global analytical R&D strategy of the company,

ensuring scientific excellence, regulatory compliance, and the development of robust analytical

methods from early research through commercial launch. The leader will drive innovation in

analytical technologies, manage multi-site teams, and ensure that all R&D products meet global

quality and regulatory standards (FDA, EMA, ICH, cGMP). The role requires deep scientific

expertise, proven global team management experience, and the ability to influence strategic

decision-making across R&D, manufacturing, and quality control functions.

Key Deliverables

 Strategic Leadership & Innovation: Define and implement the global analytical

development strategy, aligning departmental objectives with the company's overall business

and R&D goals. Drive innovation by evaluating and implementing cutting-edge analytical

technologies and automation.

 Analytical Method Development & Validation: Oversee the development, optimization,

validation, and transfer of robust analytical methods for characterization, release, and

stability testing of raw materials & API’s

 Regulatory Compliance & Submissions: Ensure all analytical activities comply with global

regulatory requirements (e.g., ICH, FDA, EMA, GMP). Accountable for authoring, reviewing,

and approving high-quality analytical documentation for regulatory submissions (IND, NDA,

BLA, etc.) and leading the defence of analytical strategies during health authority

inspections.

 Team & Resource Management: Lead, mentor, and manage multi-disciplinary, global

teams of scientists and analysts (100+ staff across sites). Foster a culture of scientific

excellence, collaboration, and continuous improvement, managing resource allocation and

budget effectively.

 Cross-Functional Collaboration: Partner with R&D, manufacturing and quality assurance

to ensure seamless project execution and technology transfer to commercial sites.

Sai Life Sciences Limited

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 Problem-Solving & Data Analysis: Provide expertise and leadership in troubleshooting

complex analytical issues, including out-of-specification (OOS) or out-of-trend (OOT)

results, and ensure rigorous data analysis and interpretation to support key decisions.

 Project Management: To oversee all the analytical progress on various projects to deliver

the tasks as per the project timelines by regularly scheduling scientific reviews of the projects

to ensure that the projects / tasks are ON TRACK and leading to the project delivery with

expected high QUOTIF

 Customer Engagement and Interaction: Participation in customer calls to address any

critical issues related to analytics and ensure the timely support to clients. Handling and

participation in customer visits and audits on need basis

 Lab Maintenance, Upkeep and Safety: Ensure proper lab upkeep, proper housekeeping

and develop a culture of 5S in all the labs. Ensure compliance with Safety practices (HSE)

and housekeeping within the department. Ensure regular upgradation of the lab

instrumentations and infrastructure as per the global standards and the proper upkeep of

the instruments.

 Budget and Monitoring: Manage the activities within the budgets (as per quotes) and

review of quotes provided to clients.

Required Qualifications & Experience:

 Education: A Ph.D. in Analytical Chemistry

 Experience: Extensive proven experience (typically 20+ years) in analytical development

within the pharmaceutical/similar industry, with a minimum of 5 years in a senior leadership

role managing global, cross-functional teams.

 Technical Expertise: Deep expertise in modern analytical techniques and instrumentation

(HPLC, UPLC, GC, MS, FTIR, dissolution, etc.) and a strong understanding of control

strategies and product characterization.

 Skills:

o Strong strategic thinking, problem-solving, and decision-making skills.

o Excellent written and verbal communication skills, with experience influencing senior

stakeholders and authoring complex regulatory documents in English.

o Proven ability to lead through change and manage in a complex, multi cultural and

matrixed environment.

o Strong knowledge of global regulatory landscapes and quality systems (ICH, FDA,

EMA, cGMP/GLP)

Sai Life Sciences Limited

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