Umedicalabs - Head - Analytical Research & Development (18-20 yrs)

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i., Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc.

UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

We are seeking a dynamic and experienced Analytical Head - R&D for our R&D Centre to lead our ADL department.

This position is based at our R&D Centre at Turbe and will report to our CSO.

The remuneration package will be commensurate with the incumbent's professional experience and in line with market standards.

Essential skills and experience:

- The Analytical R&D Head will lead the research and development efforts related to analytical chemistry, driving the innovation, development, and validation of analytical methods to support product development, manufacturing, and regulatory compliance.

- Should have Minimum of 18 years to 20 years of experience in analytical R&D, including at least 5 years in a leadership role.

- Proven expertise in method development, validation, and transfer.

- This role involves strategic planning, team leadership, project management, and cross-functional collaboration to achieve organizational goals in the pharmaceutical, chemical, or related industries.

Leadership & Strategy:

- Develop and implement strategic plans for the Analytical R&D department.

- Ensure alignment of departmental objectives with organizational goals.

- Drive innovation in analytical technologies and methodologies.

Analytical Method Development and Validation:

- Oversee the development, optimization, and validation of analytical methods for raw materials, intermediates, and final products.

- Ensure methods meet regulatory and industry standards (e., ICH, USP, FDA, EMA)

Team Management:

- Lead and mentor a team of analytical scientists and researchers.

- Foster a culture of scientific excellence, collaboration, and continuous learning.

- Conduct performance reviews and facilitate career development.

Project Management:

- Manage multiple R&D projects simultaneously, ensuring timely delivery of results.

- Collaborate with cross-functional teams, including formulation, production, and quality assurance.

- Allocate resources effectively to meet project requirements.

Regulatory Compliance:

- Ensure all analytical activities comply with global regulatory requirements and quality standards.

- Support regulatory submissions with comprehensive analytical data and documentation.

- Respond to regulatory queries related to analytical methods and data.

Data Analysis & Reporting:

- Review and interpret complex analytical data to ensure accuracy and reliability.

- Prepare detailed technical reports, method validation protocols, and standard operating procedures (SOPs).

Technology & Innovation:

- Evaluate and implement advanced analytical techniques and instrumentation (e., HPLC, GC, LC-MS, NMR, FTIR).

- Stay updated with emerging trends and technologies in analytical science

Problem-Solving:

- Address analytical challenges in product development and manufacturing.

- Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results.

Dosage form expertise:

- Well versed on development and validations of Solid Orals.

- Injectables, Liquids and complex generics must.

Preferred Education requirements:

- Ph.d or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.

Technical Expertise:

- Proficient in modern analytical instrumentation and techniques.

- Deep understanding of regulatory guidelines (e., ICH Q2, FDA, EMA).

Analytical Thinking:

- High level of problem-solving and decision-making skills.

- Ability to manage complex data and draw actionable insights.

Project Management:

- Strong organizational skills with experience in managing cross-functional projects.

Regulatory Knowledge:

- Familiarity with global regulatory environments and submission processes.

Work Environment:

- Laboratory and office settings.

- Occasional travel for conferences, vendor management, plant and regulatory meetings