General Manager - Extractable & Leachable and Nitrosamine
- Fusion Scientific
- 15 - 24 years
- Mumbai
- 15 days ago
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Job Description
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 Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Head - R & DEmployement Type: Full timeContact Details:
Company: Fusion ScientificLocation(s): Mumbai
Keyskills: GC-MS Icp-Ms Analytical Method Development Leachable LCMS HRMS Analytical Method Validation Nitrosamine Analytical Research Extractable NDSRi
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Fusion Scientific
Fusion Scientific Laboratories Private Limited is an USFDA approved Contract Research Organisation providing services pertaining to Formulation Development & Analytical Solutions to pharmaceutical companies globally.
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