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.
Job Title: Quality Assurance Manager Location: Rabale, Navi Mumbai Experience: 10 15 years Department: Quality Assurance Employment Type: Full-time Reports To: Quality Head About Fusion Scientific Laboratories Fusion Scientific Laboratories is a USFDA and EMA accredited pharmaceutical laboratory based in Rabale, Navi Mumbai , offering world-class services in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services (CDMO) . We partner with pharmaceutical companies globally to deliver compliant and innovative solutions across the drug development lifecycle. Position Overview We are looking for a highly experienced Quality Assurance Manager to lead quality oversight for oncology product development, formulation, and pilot manufacturing , with a strong focus on compliance in both production and Quality Control (QC) Laboratory environments. The ideal candidate will have in-depth knowledge of GMP, regulatory compliance , and oncology product handling , with proven experience supporting regulatory inspections and audit readiness . Key Responsibilities General Quality Assurance Responsibilities Ensure end-to-end GMP compliance across formulation development, pilot manufacturing, and quality control functions for oncology products. Review and approval of Batch Manufacturing Records (BMRs) , analytical reports, and validation protocols for oncology drug substances and products. Lead deviation investigations , OOS/OOT management , and CAPA implementation in a timely and compliant manner. Maintain and improve quality systems such as Change Control, Risk Assessment, Quality Metrics, and Audit Trails. Ensure effective training programs are in place for staff involved in oncology manufacturing and testing, including PPE use and containment protocols. Support and host regulatory audits and client inspections; ensure constant audit readiness . Implement and monitor Data Integrity (ALCOA+) practices across all functions. Quality Oversight of cGMP QC Laboratory Oversee and ensure compliance of the QC laboratory with current GMP and GLP requirements specific to oncology products. Verify compliance with analytical method SOPs , regulatory compendia (USP, EP, IP), and internal specifications. Support implementation of Good Documentation Practices (GDP) in laboratory notebooks, logbooks, and electronic systems. Monitor proper functioning, calibration , and preventive maintenance of all critical QC instruments (e.g., HPLC, GC, ICP-MS, LC-MS/MS, etc.). Ensure environmental monitoring (EM) and microbiological testing for sterile oncology products are performed and reviewed per SOP. Facilitate timely investigation and closure of laboratory incidents, deviations, and out-of-specification (OOS) results. Collaborate with the QC and Analytical Development teams to ensure smooth and compliant execution of: Method transfers Reference standard qualification Sample management and chain of custody Oversee the archiving and retention of QC documents and raw data in accordance with regulatory and company requirements. Required Qualifications & Experience Master’s degree in Pharmaceutical Sciences, Chemistry, or a related discipline . 10–15 years of progressive experience in Quality Assurance , with exposure to oncology formulations , pilot-scale manufacturing , and cGMP QC laboratories . In-depth knowledge of ICH guidelines , USFDA, EMA regulatory expectations, and WHO GMP . Prior experience supporting regulatory inspections and/or client audits in a CDMO or oncology manufacturing setup. Strong understanding of HPAPI containment protocols , analytical method validation , and data integrity controls . Key Competencies Expertise in oncology product QA , QC laboratory compliance , and GMP system management Strong leadership and cross-functional collaboration skills Sound decision-making and risk assessment capabilities Proficiency in regulatory documentation and audit management Detail-oriented with a strong sense of ownership and accountability Why Join Fusion Scientific Laboratories? Be part of a growing, USFDA and EMA-accredited pharmaceutical laboratory focused on oncology innovation . Collaborate with top-tier pharmaceutical clients across the globe in a CDMO environment . Access cutting-edge technologies, a strong quality culture, and opportunities for professional advancement. Competitive salary, supportive leadership, and a high-performance work environment.
Location: Rabale, Navi Mumbai Experience: 2 to 7 years Industry: Pharmaceutical / Analytical Research Department: Analytical Research and Development (AR&D) Employment Type: Full-time About Us Fusion Scientific Laboratories is a globally recognized, USFDA and EMA accredited pharmaceutical laboratory located in Rabale, Navi Mumbai. We specialize in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services (CDMO) . Our commitment to innovation, quality, and regulatory excellence positions us as a trusted partner to leading pharmaceutical companies around the world. Position Overview We are seeking dynamic and detail-oriented professionals for the role of Senior Research Analyst , Executive , or Senior Executive in our Analytical Development team. The ideal candidate will have 2 to 7 years of hands-on experience in using advanced analytical instrumentation including ICP-MS, Ion Chromatography, GC, and GC-MS . The role involves developing and validating analytical methods, performing batch analysis, and supporting the overall analytical strategy for drug substances and drug products. Key Responsibilities Analytical Method Development for drug substances and drug products using ICP-MS, Ion Chromatography, GC and GC-MS. Analytical Method Validation in compliance with regulatory guidelines (ICH, USFDA, EMA). Routine and Stability Sample Analysis using validated methods to support formulation and process development. Perform instrument calibration, maintenance , and troubleshooting to ensure smooth lab operations. Prepare protocols, method development reports, validation reports , and SOPs as per regulatory standards. Conduct investigations , deviations, and ensure proper data integrity and documentation in line with GMP/GLP guidelines. Collaborate with cross-functional teams including Formulation, QA, and Regulatory Affairs for project deliverables. Ensure compliance with cGMP, GLP, and regulatory audit requirements . Required Skills & Qualifications Masters degree in Pharmaceutical Sciences, Analytical Chemistry, or related field . 2 to 7 years of relevant industry experience in pharmaceutical analytical development. Proficient in handling and troubleshooting ICP-MS, Ion Chromatography, GC, and GC-MS instruments. Strong understanding of regulatory guidelines (ICH, USFDA, EMA) related to analytical method development and validation. Experience in batch analysis of pharmaceutical products. Knowledge of GMP/GLP practices , data integrity , and regulatory documentation. Ability to manage multiple projects with attention to detail and accuracy. Excellent verbal and written communication skills. Why Join Us Be part of a fast-growing, globally accredited laboratory setting benchmarks in pharmaceutical services. Work with cutting-edge technologies and industry experts. Opportunities for professional growth and skill development. Competitive salary and performance-based incentives.
Job Roles & Responsibilities: First point of contact for HR -related queries from employees and external partners. Pre-Joining ,Onboarding and Exit Formalities Leave & Attendance Management in HRMS Maintain Employee Database , Personal Files and HR documentation. Handling and managing Employee Engagement Activities and events Admin activities Should have knowledge of statutory compliance ( Shop and Establishment Act, PF, ESIC, etc) Requirements: Excellent communication skills Strong organization and analytical skills Proficiency in Microsoft Office Excellent interpersonal skills Ability to manage and handle multiple tasks Outstanding problem-solving skills Exceptional attention to detail Strong follow-up skills
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