Head of Department - Bioanalytical (BA/BE Studies)Job Responsibilities
1. Strategic & Scientific Leadership
· Provide overall scientific and technical direction for the bioanalytical department, ensuring alignment with organizational goals and client requirements.
· Drive the development and implementation of new bioanalytical methodologies and technologies to enhance laboratory capabilities and competitiveness.
· Stay abreast of emerging trends in bioanalysis and regulatory science, and guide the department in adopting innovative approaches.
2. Regulatory Compliance & Quality Assurance
· Ensure 100% compliance with global regulatory guidelines including USFDA, EMA, ANVISA, MHRA, WHO, and ICH for GLP/GCP bioanalytical studies.
· Lead and represent the department during regulatory inspections, sponsor audits, and client visits, acting as the primary point of contact for all regulatory and quality-related matters.
· Oversee the preparation, review, and finalization of SOPs, protocols, validation reports, and study reports, ensuring they meet the highest quality standards.
· Implement and monitor robust quality systems to ensure data integrity (ALCOA+ principles) throughout the analytical workflow.
3. Team Leadership & People Management
· Lead, mentor, and manage a team of bioanalytical scientists, research associates, and support staff, fostering a culture of excellence, collaboration, and continuous learning.
· Oversee recruitment, training, performance evaluation, and career development of all department personnel.
· Allocate resources effectively—including manpower, instruments, and consumables—to ensure optimal productivity and timely project delivery.
4. Operational Management & Project Oversight
· Oversee the end-to-end execution of bioanalytical studies for BA/BE projects, including method development, validation, and sample analysis.
· Monitor study progress against timelines, troubleshoot scientific and operational challenges, and implement corrective actions as needed.
· Ensure the smooth operation and preventive maintenance of all critical equipment, including LC-MS/MS (AB Sciex API 4000, Waters TQ-S), HPLC, and UPLC systems.
· Manage the departmental budget, including capital expenditure planning, cost control, and financial forecasting.
5. Client & Stakeholder Engagement
· Act as the senior scientific liaison for clients, sponsors, and CRO partners, providing expert consultation on bioanalytical strategy and study design.
· Present study findings and departmental capabilities to clients and regulatory bodies, building trust and long-term partnerships.
· Collaborate with cross-functional teams including Clinical Operations, Pharmacokinetics, and Regulatory Affairs to ensure seamless study execution.
6. Documentation & Data Integrity
· Ensure meticulous documentation practices, including raw data recording, chromatographic data review, and method book writing, in compliance with regulatory expectations.
· Review and authorize all analytical data and reports before client submission or regulatory filing.
· Oversee the maintenance of environmental and equipment logs, calibration records, and other laboratory documentation as per SOPs.
7. Continuous Improvement & Innovation
· Champion process improvement initiatives to enhance efficiency, reduce turnaround times, and improve cost-effectiveness.
· Evaluate and introduce new software, automation tools, and analytical technologies to modernize laboratory operations.
· Encourage the team to participate in scientific conferences, workshops, and training programs to stay updated with recent trends and methodologies.
Summary of Key Competencies for this Role
Competency
Description
Regulatory Expertise
Deep knowledge of USFDA, ANVISA, MHRA, EMA, and ICH guidelines for bioanalysis.
Technical Proficiency
Expert-level hands-on and theoretical knowledge of LC-MS/MS, HPLC, UPLC, and method development/validation.
Leadership & Mentoring
Proven ability to manage, develop, and inspire a team of scientists in a high-pressure CRO/Pharma environment.
Project Management
Skilled in planning, resource allocation, timeline management, and client communication.
Quality Mindset
Strong commitment to data integrity, documentation, and regulatory compliance.
Problem-Solving
Ability to troubleshoot complex scientific and operational challenges effectively.
Qualifications & Skills:
Education: B. E -Bio Technology/ M.Sc./B. Pharm/M. Pharm in Chemistry/Pharmaceutical Sciences.
Experience: 10-15 years in pharmaceutical operations of LC-MS/MS(AB Sciex API400 & waters TQ-S) & HPLC & UPLC experience in:
HPLC/UPLC (Method development/validation preferred).
Regulatory Knowledge: USFDA, ANVISA, MHRA
Pay: ₹90,000.00 - ₹200,000.00 per month
Benefits:
Work Location: In person
