About UMEDICA: UMEDICA is a vertically integrated pharmaceutical company engaged in the manufacturing and export of a wide range of finished formulations, including Injectables, Tablets, Capsules, Suspensions, and Dry Syrups. Established in 1983, UMEDICA operates in over 85 countries, including the EU, UK, USA, Canada, Australia, the Middle East, Central & South America, Africa, Asia, and CIS countries. The company’s manufacturing facility in Vapi (Gujarat) is approved by global regulatory authorities.

Position: Analytical Head – R&D

Location: R&D Centre, Turbe
Reporting to: Chief Scientific Officer (CSO)
Remuneration: Competitive and commensurate with experience and market standards.

Job Overview:

The Analytical Head – R&D will lead the Analytical Development Laboratory (ADL) department, overseeing research and development efforts related to analytical chemistry. This role involves strategic planning, team leadership, project management, and cross-functional collaboration. The individual will drive innovation, develop and validate analytical methods, and ensure regulatory compliance.

Key Responsibilities:

1. Leadership & Strategy:

• Develop and implement strategic plans for the Analytical R&D department.
• Align departmental objectives with organizational goals.
• Foster innovation in analytical technologies and methodologies.

2. Analytical Method Development and Validation:

• Supervise the development, optimization, and validation of analytical methods for raw materials, intermediates, and final products.
• Ensure all methods comply with regulatory and industry standards (e.g., ICH, USP, FDA, EMA).

3. Team Management:

• Lead and mentor a team of analytical scientists and researchers.
• Cultivate a culture of scientific excellence, collaboration, and continuous learning.
• Conduct performance reviews and facilitate career development opportunities.

4. Project Management:

• Manage multiple R&D projects concurrently, ensuring timely delivery of results.
• Collaborate with cross-functional teams, including formulation, production, and quality assurance.
• Allocate resources effectively to meet project requirements.

5. Regulatory Compliance:

• Ensure all analytical activities adhere to global regulatory requirements and quality standards.
• Support regulatory submissions with comprehensive analytical data and documentation.
• Address regulatory queries related to analytical methods and data.

6. Data Analysis & Reporting:

• Review and interpret complex analytical data for accuracy and reliability.
• Prepare detailed technical reports, validation protocols, and standard operating procedures (SOPs).

7. Technology & Innovation:

• Evaluate and implement advanced analytical techniques and instrumentation (e.g., HPLC, GC, LC-MS, NMR, FTIR).
• Stay updated on emerging trends and technologies in analytical science.

8. Problem-Solving:

• Address analytical challenges in product development and manufacturing.
• Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results.

9. Dosage Form Expertise:

• Oversee development and validation of Solid Orals, Injectables, Liquids, and complex generics.

Candidate Profile:

Preferred Education:

• Ph.D. or Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.

Essential Skills & Experience:

• 18-20 years of experience in analytical R&D, with at least 5 years in a leadership role.
• Expertise in method development, validation, and transfer.
• Proficient in modern analytical instrumentation and techniques.
• Strong knowledge of regulatory guidelines (e.g., ICH Q2, FDA, EMA).

Competencies:

• Analytical Thinking: Exceptional problem-solving and decision-making skills.
• Project Management: Strong organizational skills with experience managing cross-functional projects.
• Regulatory Knowledge: Familiarity with global regulatory environments and submission processes.
• Communication: Excellent verbal and written communication skills.

Work Environment:

• Laboratory and office settings.
• Occasional travel for conferences, vendor management, plant visits, and regulatory meetings.

Application Details: Last Date to Apply: 31st December 2024
How to Apply: Share your updated resume at avinash.s@umedicalabs.com.