Executive Validation Lab Job at Enzene Biosciences for biologics professionals with GMP, HPLC, ELISA experience.
Company: Enzene Biosciences
Job Title: Executive – Validation Lab
Location: Pune, Maharashtra, India
Job Type: Full-Time, Permanent
Experience Required: 2–5 Years
Qualification: M.Sc / M.Pharm / Master’s Degree in Biotechnology or related Life Sciences
Application Mode: Online
Job Status: Verified Job
About the Company
Enzene Biosciences is a leading biopharmaceutical organization specializing in the development, manufacturing, and commercialization of biosimilars and biologics. With state-of-the-art facilities and a strong focus on innovation, Enzene supports global healthcare needs by delivering high-quality, affordable biologic medicines.
The company operates in a highly regulated environment, adhering strictly to global regulatory standards such as cGMP, data integrity, and quality management systems. Enzene Biosciences is known for its strong scientific culture, compliance-driven processes, and commitment to continuous learning and professional development.
Working at Enzene provides professionals the opportunity to gain exposure to advanced analytical technologies, global regulatory expectations, and complex biologics validation programs. The organization encourages teamwork, accountability, and excellence across all functions. Executive Validation Lab Job at Enzene Biosciences
Job Details
- Job Title: Executive – Validation Lab
- Department: Validation Lab
- Location: Pune, Maharashtra
- Employment Type: Permanent
- Experience Level: Executive
- Industry: Biopharmaceuticals / Biotechnology / Life Sciences
- Work Mode: On-site
This position is part of the Validation Laboratory team and plays a key role in ensuring analytical accuracy, regulatory compliance, and quality assurance for biologics and biosimilar products. Executive Validation Lab Job at Enzene Biosciences
Job Description
The Executive – Validation Lab will be responsible for performing analytical method validation and verification activities in compliance with regulatory guidelines. The role involves hands-on execution of stability studies, biosimilarity assessments, and laboratory documentation for drug substances, drug products, and in-process samples. Executive Validation Lab Job at Enzene Biosciences
The selected candidate will work closely with cross-functional teams, including Quality Assurance, Manufacturing, and Analytical Development, to support validation activities in a cGMP-compliant environment. This position requires strong technical expertise, attention to detail, and a sound understanding of regulatory expectations in biologics and biosimilar testing.
This role is ideal for professionals seeking long-term growth in biopharmaceutical quality control and validation laboratories. Executive Validation Lab Job at Enzene Biosciences
Key Responsibilities
As an Executive – Validation Lab, your responsibilities will include:
- Performing method validation and method verification for drug substances (DS), drug products (DP), and in-process samples
- Conducting stability studies as per approved protocols and regulatory guidelines
- Executing IRS qualification and supporting biosimilarity assessment activities
- Preparing, reviewing, and maintaining controlled laboratory documents, including:
- Specifications
- Standard Test Procedures (STPs)
- Standard Operating Procedures (SOPs)
- Technical Data Sheets (TDS)
- Certificates of Analysis (COA)
- Method Validation Protocols (MVP)
- Method Validation Reports (MVR)
- Method Transfer Reports (MTR)
- Coordinating with external vendors for calibration of laboratory instruments and equipment
- Supporting in-house calibration, qualification, and verification activities in coordination with MVL personnel
- Managing validation laboratory inventory including chemicals, reference standards, kits, and consumables
- Ensuring proper stock control, material traceability, and inventory documentation
- Maintaining laboratory equipment, instrument usage records, and logbooks
- Conducting analyst qualification programs and providing training to Validation Lab team members
- Initiating, documenting, investigating, and tracking Quality Management System (QMS) activities
- Supporting deviation handling, CAPA implementation, and investigation reports
- Ensuring strict compliance with current Good Manufacturing Practices (cGMP)
- Adhering to workplace safety rules and laboratory safety guidelines
- Supporting audits, inspections, and regulatory queries as required
- Performing any additional responsibilities assigned by the reporting manager
Executive Validation Lab Job at Enzene Biosciences
Required Experience and Technical Skills
Candidates must have 2–5 years of relevant hands-on experience in analytical or validation laboratories within pharmaceutical or biopharmaceutical organizations. Executive Validation Lab Job at Enzene Biosciences
Mandatory Technical Expertise
Hands-on experience with the following analytical techniques is required:
- CEX-HPLC
- SE-HPLC
- ELISA
- Host Cell DNA (HCDNA) analysis by RT-PCR
- Maurice
- SOLO VPE
- Host Cell Protein (HCP) analysis
- Peptide Mapping
- Glycan Analysis
- Capillary Electrophoresis
Experience in biologics or biosimilar analytical validation is highly preferred.
Skills and Competencies
- Strong understanding of cGMP, data integrity, and regulatory laboratory practices
- Excellent documentation and technical writing skills
- High attention to detail and analytical accuracy
- Ability to work independently as well as in cross-functional teams
- Good communication and coordination skills
- Proactive approach toward quality and compliance
- Ability to manage multiple tasks in a regulated environment
Educational Qualification
- M.Sc / M.Pharm / Master’s Degree in Biotechnology or related life science disciplines from a recognized university or institute
Salary and Benefits
- Expected Salary: ₹4,00,000 – ₹6,00,000 per annum (CTC), depending on experience and skill set
- Permanent employment with long-term career stability
- Exposure to global biologics and biosimilar validation projects
- Opportunity to work in a cGMP-compliant and regulatory-driven environment
- Professional training, analyst qualification, and skill development programs
- Career growth opportunities within a rapidly expanding biopharmaceutical organization
Executive Validation Lab Job at Enzene Biosciences
Why You Should Join Enzene Biosciences
Enzene Biosciences offers a strong platform for professionals aiming to build a career in biologics quality and validation. You will work with advanced analytical technologies, experienced scientific teams, and globally aligned quality systems. Executive Validation Lab Job at Enzene Biosciences
The organization promotes continuous learning, technical excellence, and regulatory compliance. This role allows you to contribute directly to high-impact biopharmaceutical products while strengthening your expertise in validation, biosimilarity, and analytical science. Executive Validation Lab Job at Enzene Biosciences
FAQs
Is this a permanent role?
Yes, this is a full-time permanent position.
Is this role suitable for freshers?
No, this role requires 2–5 years of relevant hands-on laboratory experience.
What type of products will I work on?
You will work on biologics and biosimilar drug substances and drug products.
Is this an on-site role?
Yes, the role is based at Enzene Biosciences’ Pune facility.
Will training be provided?
Yes, professional training and analyst qualification programs are part of the role.
How to Apply
Interested and eligible candidates can apply through the official application link provided in the job listing. Ensure your resume highlights relevant analytical techniques, validation experience, and cGMP exposure. Executive Validation Lab Job at Enzene Biosciences
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