Analytical Head

We are seeking an experienced and dedicated Analytical Head - R&D to join our team at Glochem Industries Private Limited. The ideal candidate will possess a postgraduate degree (MSc in Analytical Chemistry) and have over 13 years of experience in the field. This role involves leading our analytical team, ensuring timely execution of activities, maintaining high standards of quality, and adhering to regulatory standards. You will benefit from this role by developing your leadership skills, influencing strategic decisions, and contributing to the advancement of our analytical methods. If you are passionate about analytical chemistry and looking for a challenging and rewarding leadership position, we invite you to apply.

Job Details:

• Industry: Pharmaceutical API Manufacturing
• Department: Analytical Research & Development (AR&D)
• Role: AR&D Head
• Required by Date: February, 2025
• Location: Hyderabad, Bollaram
• Compensation: 12 - 15 Lakhs per Annum
• Experience: 13+ Years of Experience
• Qualification: Post-graduation (MSc in Analytical Chemistry)

Technical Responsibilities:

1. Ensure adherence to timelines for the execution of analytical activities, maintaining high standards of quality and efficiency.
2. Lead and guide the analytical team through the development of new methods, providing mentorship and direction to achieve project goals effectively.
3. Collaborate with senior managers and decision-makers to identify and resolve analytical problems, offering informed insights and strategic solutions.
4. Prepare and review Analytical Method Validation (AMV) protocols and reports, ensuring accuracy and compliance with industry standards.
5. Stay updated with the latest regulatory guidelines and ensure the team is well-informed and compliant.
6. Conduct pre-formulation and compatibility studies.
7. Develop and validate test methods.
8. Transfer test methods to Quality Control Labs (internal and external) and CROs.
9. Conduct stability studies (developmental and pivotal) to support new product development or lifecycle management.
10. Assess impurity and degradation pathways.
11. Provide technical justifications for analytical methods and results.
12. Investigate laboratory and non-conformance issues to identify root causes and implement corrective actions.

Regulatory Compliance:

1. Ensure all analytical activities comply with local, regional, and global regulatory requirements.
2. Prepare and review documents for regulatory submissions, ensuring accuracy and compliance.
3. Maintain high-quality standards in all analytical processes to meet regulatory expectations.

Method Development:

1. Plan and execute method development strategies.
2. Utilize various analytical techniques such as HPLC, GC, LC-MS, NMR, and spectroscopy for method development.
3. Optimize methods to improve efficiency, accuracy, and reliability.

Communication and Reporting:

1. Communicate project progress to management, business partners, and team members.
2. Prepare detailed reports, protocols, and procedures, ensuring high standards of documentation and accuracy.
3. Attend and/or facilitate project and technical meetings.

Continuous Improvement:

1. Conduct regular reviews of analytical processes to identify areas for improvement.
2. Provide training and development programs for team members to enhance their skills and knowledge.

Energy Conservation and Cost Reduction:

1. Conserve energy and reduce costs during the solvent recovery process.
2. Implement strategies for energy conservation and cost reduction.

General Expectations and Past Experiences:

• In-depth knowledge of regulatory requirements (e.g., FDA, ICH, etc.) relevant to the industry.
• Strong analytical and problem-solving abilities, with a keen eye for detail.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to adapt to evolving industry standards and guidelines.
• Strong documentation and report preparation skills.
• Proficiency in English.
• Ability to work independently and take ownership of tasks.
• Prior experience working with various analytical method development activities.
• Experience in solvent recovery and distillation.
• Familiarity with quality control and documentation.
• Safety-conscious.