Specialist - Research & Development (2-10 yrs)

Job Overview:

We are seeking a highly motivated and skilled Analyst to join our Analytical Development team within our R&D department.

The successful candidate will be responsible for the development, validation, and execution of analytical methods to support the development and quality control of Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), raw materials, and other chemical entities.
This role requires a strong foundation in analytical chemistry, hands-on experience with various analytical techniques, meticulous documentation skills, and a commitment to maintaining high quality and compliance standards within a pharmaceutical/chemical industry setting.

Key Responsibilities:

- Analytical Method Development: Design, develop, and optimize robust and reliable analytical methods for the analysis of APIs, KSMs, raw materials, intermediates, and finished products.
This includes chromatographic methods (HPLC, GC), spectroscopic techniques, and other relevant analytical procedures.

- Method Validation and Transfer: Plan, execute, and document method validation studies in accordance with ICH guidelines and internal procedures.

Participate in the transfer of validated analytical methods to quality control laboratories or contract research organizations (CROs).

- Instrument Operation and Maintenance: Proficiently operate and maintain a range of sophisticated analytical instruments, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Inductively Coupled Plasma (ICP) spectroscopy, UV-Vis spectrophotometers, and other relevant laboratory equipment.

- Troubleshoot instrument issues and perform basic maintenance as required.

- Wet Lab Analysis: Perform various wet chemical analyses, including titrations (acid-base, redox, complexometric, precipitation), loss on drying (LOD), residue on ignition (ROI), and other classical analytical techniques.

- Documentation and Reporting: Prepare accurate, comprehensive, and timely analytical reports, method validation protocols and reports, standard operating procedures (SOPs), and other relevant documentation in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

Review analytical data and ensure its integrity and accuracy.

- Quality and Compliance: Adhere strictly to established quality standards, laboratory safety procedures, and regulatory guidelines (e.g., ICH, GMP).

Participate in internal audits and ensure that all analytical activities are conducted in compliance with relevant regulations and SOPs.

- Problem Solving and Troubleshooting: Investigate and resolve analytical issues, method failures, and out-of-specification (OOS) results.

Participate in root cause analysis and implement corrective and preventive actions (CAPAs).

- Collaboration and Communication: Effectively collaborate with other departments, including Formulation Development, Quality Control, and Regulatory Affairs.

Communicate analytical findings and progress updates clearly and concisely.

- Continuous Improvement: Stay abreast of the latest advancements in analytical techniques and technologies.

Identify opportunities for process improvements and contribute to the optimization of analytical workflows.

Qualifications:

Education: Masters degree in Chemistry, Analytical Chemistry, Pharmaceutical Analysis, or a related scientific discipline.

Experience:

- Minimum of 2 to 10 years of relevant experience in analytical development within the Pharmaceutical or Chemical Industry.

- Proven experience in developing and validating analytical methods for APIs, raw materials, and related substances.

- Hands-on experience in operating and troubleshooting analytical instruments such as HPLC, GC, and ICP.

- Demonstrated experience in performing wet chemical analyses and interpreting results.

- Familiarity with regulatory guidelines (ICH, GMP, GLP) and quality control principles.

- Strong documentation and report writing skills.

Preferred Candidates:

- Graduates from Sardar Patel University.

- Graduates from The Maharaja Sayajirao University (MSU)