2 Leachable Jobs

Job Summary Job Title Research Associate I Location Whitefield, Bangalore Shift General Essential Duties and Responsibilities: Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines. Make sound technical recommendations in routine analytical activities. Provide analysis/redesign of key experimental procedures. Produce scientific experimental data based on written procedures like method of analysis, protocols etc. Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc Provide input to select analytical techniques and procedures to solve problems within area of responsibility. Apply technical theories and principles to projects within area of expertise. Independently analyze and propose solutions to research challenges. Learn newer analytical techniques to enhance the capability and productivity. Author documents like Method of analysis/ protocols/ reports Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory. Participate and take ownership of equipment installation and qualification activities as per QMS. Document laboratory work performed pers GDP. Work according to appropriate quality standards and quality principle (e.g., Data Integrity, ALCOA) Follow Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement. Qualifications: Hands-on experience in chromatographic and/ or spectral techniques like LC-MS/MS, GC-MS, and/or ICP-MS/ ICP-OES. Operation of analytical tools/ instruments (weighing balances, pH meters etc.) and wet chemistry sample preparation techniques. Should have analytical problem-solving skills, high learning agility, innovative experimental attitude along with good presentation skills. Excellent written and verbal communication skills in English. Demonstrates an inclusive attitude and an ability to collaborate with team members and cross-functional team members for project deliverables. Ability to objectively assess, organize, and clearly communicate information. Ability to interpret available information and make recommendations to resolve technical challenges. Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner. Provide and accept critical feedback from others in a constructive manner. Adapt to changes and have an agile mindset. Embrace diversity and inclusion, value differences. Education and/or Experience: Educational Qualification: Postgraduate/ Ph. D. in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ Ph. D.) Professional Experience: 3 to 6 years of relevant experience

Job Title: General Manager Analytical Laboratory (Extractables & Leachables and Nitrosamine Impurities) Location: Rabale, Navi Mumbai Company: Fusion Scientific Laboratories Experience: 15+ Years About Fusion Scientific Laboratories: Fusion Scientific Laboratories is a USFDA and EMA-accredited laboratory based in Rabale, Navi Mumbai. We provide specialized services in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services to leading pharmaceutical clients worldwide. With a robust focus on regulatory compliance and scientific excellence, Fusion Scientific delivers innovative, high-quality solutions to meet evolving industry needs. Position Overview: We are looking for a strategic and technically strong General Manager to lead our Analytical Laboratory , with specialized expertise in Extractables & Leachables (E&L) and Nitrosamine Impurities . In addition to managing laboratory operations, this role requires a strong business acumen to drive growth, build client relationships, and expand our service portfolio. The ideal candidate will combine deep scientific expertise with leadership and business development capabilities. Key Responsibilities: 1. Technical and Operational Leadership: Lead and oversee analytical operations related to E&L and nitrosamine impurities. Ensure robust method development, validation, and execution using advanced instrumentation (GC-MS, LC-MS/MS, HRMS). Maintain high scientific standards, ensuring all activities comply with ICH, USFDA, EMA, and other global regulatory requirements. 2. Quality and Compliance Oversight: Ensure all laboratory practices meet GMP, GLP, and data integrity standards. Proactively prepare for regulatory inspections and client audits. Oversee documentation, quality assurance, and submission-ready reporting. 3. Business Development and Client Engagement: Identify new business opportunities in E&L and nitrosamine testing, both domestic and international. Build and nurture strong relationships with existing and prospective clients. Support the commercial team with technical insights during proposal development, client presentations and contract negotiations. Contribute to revenue growth through expansion of service offerings and strategic partnerships. Represent Fusion Scientific at industry conferences, webinars, and networking events. 4. Team Leadership and Development: Lead and mentor a 45 plus high-performing team of scientists and technical staff. Drive a culture of accountability, continuous learning, and scientific excellence. Conduct resource planning, recruitment, and training for analytical functions. 5. Strategic Planning and Innovation: Identify trends, regulatory changes, and technological advancements to evolve laboratory capabilities. Support CAPEX planning for new technologies and equipment to enhance service capacity. Collaborate with cross-functional teams including formulation, regulatory, and quality units to offer integrated solutions. Required Qualifications & Experience: M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline. Minimum 15 years of experience in a regulated analytical laboratory, with strong domain knowledge in E&L and nitrosamine impurity testing. Proven ability to lead scientific teams and laboratory operations in a CRO or pharma setting. Strong business acumen and experience in client-facing or business development roles. Familiarity with global regulatory expectations (USFDA, EMA, ICH, etc.). Excellent communication, leadership, and negotiation skills. Why Join Fusion Scientific Laboratories? Work with a USFDA & EMA-accredited laboratory serving top-tier pharmaceutical companies. Be part of a collaborative, innovation-driven culture. Opportunity to lead both technical and commercial growth in a high-impact role. Contribute to advancing global drug safety and regulatory compliance.