Associate Manager Scientist

INDEGENE LIMITED • Jersey City, NJ

3d

About The Position

Lead the technical evaluation, characterization, and qualification of raw materials used in medical devices, including polymers, elastomers, metals, coatings, and other functional materials. Evaluate raw material testing and purchasing specifications, review supplier documentation, and establish scientifically justified acceptance criteria to ensure materials meet product, quality, and regulatory requirements.

Work with R&D, analytical sciences, quality, procurement, supplier quality, and manufacturing teams to characterize materials, assess variability, evaluate alternate materials and suppliers, and correlate raw material properties with medical device performance. Support material qualification, change control, and investigations to help ensure consistent material quality and reliable medical device manufacturing.

The role includes laboratory R&D activities and requires adherence to applicable laboratory safety procedures, strong documentation and data integrity practices, and the ability to make sound technical recommendations.

Requirements

• M.S. or M.Tech. in Materials Science and Engineering, Polymer Science, Chemistry, Analytical Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline; a B.E./B.Tech. degree in a relevant discipline may also be considered with suitable industry experience.
• 5–8 years of relevant experience in raw material characterization, analytical testing, material qualification, or specification development, preferably in the medical device, pharmaceutical, healthcare, or regulated manufacturing industry.
• Hands-on experience evaluating raw material testing specifications, acceptance criteria, and purchasing specifications.
• Experience reviewing supplier CoAs, technical data sheets, and material compliance documentation.
• Practical knowledge of analytical techniques for polymer, elastomer, metal, coating, or other functional material characterization.
• Experience with material equivalence assessments, supplier changes, root-cause investigations, and material-related quality issues.
• Familiarity with quality systems, change control, risk assessment, and technical documentation.
• Strong understanding of raw material properties, testing methodologies, specification limits, and supplier qualification requirements.
• Ability to interpret analytical data, identify specification gaps, and recommend technically justified acceptance criteria.
• Strong analytical thinking, problem-solving, technical writing, and cross-functional collaboration skills.
• Strong attention to detail, documentation practices, and data integrity.
• Effective written and verbal communication skills.

Nice To Haves

• Familiarity with ISO 13485, ISO 14971, ISO 10993, and relevant ASTM, ISO, or USP standards, as applicable.
• Understanding of medical device material compatibility, biocompatibility, sterilization, and chemical characterization requirements.
• Working knowledge of FTIR, DSC, TGA, GPC/SEC, chromatography, rheology, and mechanical testing.

Responsibilities

• Evaluate and develop raw material testing specifications, including test parameters, analytical methods, sampling requirements, and acceptance criteria.
• Review and optimize raw material purchasing specifications to align with product requirements, supplier specifications, and internal quality standards.
• Analyze supplier technical data sheets, Certificates of Analysis (CoAs), safety data sheets, and other technical documentation to assess material compliance.
• Characterize raw materials using appropriate analytical techniques, including FTIR, DSC, TGA, GPC/SEC, rheology, moisture analysis, chromatography, and mechanical testing, as applicable.
• Establish scientifically justified acceptance limits based on material properties, historical data, supplier capabilities, product requirements, and risk assessments.
• Evaluate new materials, alternate grades, and supplier changes through comparative analysis and material equivalence assessments.
• Investigate material variability, out-of-specification results, contamination, and material-related manufacturing or product performance issues.
• Support raw material qualification, supplier approval, incoming inspection optimization, change control, and nonconformance investigations.
• Assess the impact of raw material properties on medical device functionality, processability, biocompatibility, sterilization compatibility, and product reliability, as applicable.
• Collaborate with R&D, analytical, quality, procurement, and manufacturing teams to resolve material-related technical challenges.
• Prepare material evaluation reports, specification justifications, qualification protocols, and technical documentation in accordance with applicable quality-system requirements.
• Identify opportunities to improve raw material quality, strengthen supplier controls, and optimize material testing requirements.
• Perform laboratory R&D activities and follow applicable laboratory safety procedures.
• Manage multiple tasks, interpret technical information, and make sound technical recommendations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level