job title: Research associatee 1 (Vantive)

Roles and Responsibilities

Summary

We are seeking highly motivated and technically qualified extractables and leachables (E&L) scientist to execute E&L studies for Vantive’s medical devices. Collaborating with cross-functional teams to develop and implement E&L testing methods in compliance with regulatory guidelines. Staying up to date with industry developments and emerging trends in E&L testing. Candidate should have knowledge of regulatory compliance and guidelines related to E&L testing.

The ideal candidate should have hands-on experience with analytical techniques and instrumentation like mass spectrometry, spectroscopy, chromatography (LCMS 3Q, LCMS-QTOF, GCMS, GCMS-QTOF, ICPMS, UPLC, IC etc.) and demonstrate understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Quality Management Systems (QMS).

Essential Duties and Responsibilities.

This position provides hands-on Analytical Research and Development support in the laboratory under supervision to the R&D activities, particularly to Extractable and Leachable testing.

• Execute method development experiments, method validations/ qualifications.

• Perform experiments to support new product development and sustaining product projects.

• Work collaboratively with senior members of the team in activities such as sample preparation for analysis and operation of advanced analytical instruments based on various Chromatographic and Spectrometric and allied methods.

• Own equipment ownership, calibration and maintenance of equipment in the laboratory.

• Apply theory & principles and technical learnings to execute projects/ develop and improve methods and products.

• Be innovative. analyze and propose solutions to research problems.

• Recommend new analytical techniques to enhance the lab capability and productivity.

• Document laboratory work performed per Vantive’s GDP, strictly adhering to ALCOA plus principles.

• Work in compliance to current industry standards, regulatory guidelines (e.g., Data Integrity, ALCOA, ICH, ISO)

• Follow Vantive’s Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement.

• Participate in Vantive’s corporate social responsibility, imbibe the values and culture.

Qualifications.

• Understanding (working principles, instrumentation, potential applications) of hyphenated- chromatographic techniques (e.g., GCMS, GC-QTOF, LCMS, LCMS-QTOF, ICPMS)

• Good understanding of (complex) sample matrix, applicable separation methodologies and influence of sample matrix on analytical methodology/ interferences.

• Theoretically strong in spectrometric techniques like mass spectrometry & related advanced techniques and spectroscopic techniques (e.g., GCMS, GC-QTOF, LCMS, LCMS-QTOF, ICPMS)

• Hands-on experience in operation of analytical tools/ laboratory instruments (e.g., balances, pH meter, oven, centrifuge, water bath, sonicator, shaker etc.)

• Good understanding of basic wet chemistry techniques like weighing, serial dilution, pipetting techniques, sample preparation, pH measurement, filtration, evaporation, liquid- liquid extraction etc.

• Knows the formulation concepts of large volume parenteral and chemistry of solid - liquid interfacial behavior of PVC and related container closure system, generation of leachables.

• Should have high learning agility, adaptability and innovative mindset along with good presentation skills, team connect and collaboration.

• Excellent written and verbal communication skills in English.

• Ability to objectively collect, assess, organize and clearly communicate information.

• Understands the organizational priorities, commits to work assigned and meets project deliverables in a timely manner.

Education and/or Experience necessary to perform the job satisfactorily.

Graduate/ Postgraduate/ PhD in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ PhD) with 3-7 years of relevant experience.