5 Laboratory Analyst jobs in India

Job Role: Analyst- Small Molecule Bioanalytical Laboratory

Job Location: Bangalore, India

About Company:

Syngene International Ltd. (BSE: , NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Role: Analyst for the Small Molecule Bioanalytical Laboratory is a technical role responsible for conducting BA/BE studies in the laboratory. Job responsibilities include performing critical method development and validation programs, technical and regulatory compliance of all studies.

This role requires an individual with a robust background in pharmaceutics, or other related life sciences, coupled with extensive experience in the bioanalytical field, particularly within small molecule bioanalysis.

This role demands an individual with a strong commitment to compliance, integrity, and excellence in bioanalytical research, particularly in small molecule analysis.

Key Responsibilities of the Role:

• Perform the bioanalytical work including sample processing for method development, method validation and study sample analysis as per the protocol in compliance with SOPs, STPs.
• Prepare STP, MV protocol and study sample analysis protocol.
• Coordinate with maintenance department for any problems related to utilities and equipment / instrument (e.g. LC-MS/MS, HPLC, etc) failures.
• Document data generated, entries in official documents.
• Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP.
• Participate in all discussions on project-specific scientific details.

Education and Experience

Education

Masters in Pharmaceutics or other related life sciences from a reputed university.

Industry Experience

• Minimum of 3 years of experience in regulated small molecule bioanalysis
• Hands-on experience in small molecule regulated bioanalytical experiments

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

**_About the job_**
**Title:** **Principal Data Standards Analyst (Laboratory Expert)**
**Level : L2-2**
The **Principal Data Standards Analyst (Laboratory Expert)** plays a crucial role in ensuring the accurate standardization, integration, and management of laboratory data across clinical studies. This role supports **Clinical Information Governance (CIG), Trial Operations (TO)** , **Data integration,** Translational Medicine, Sample Management, and external vendors, ensuring compliance with **CDISC standards** (SDTM, CDASH, Controlled Terminology) and regulatory requirements.
The **Principal Data Standards Analyst (Laboratory Expert)** also provides specialized oversight on laboratory data handling, collaborating with internal teams and external central laboratories to mitigate risks related to biomarker, genomic, and flow cytometry data. This role is instrumental in managing laboratory data mapping, governance, and compliance to **support regulatory submissions and clinical study execution** .
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Clinical Information Governance team as Data Standards Analyst and you'll help shape the future of Clinical Data Standards at Sanofi and across our industry.
**Main responsibilities:**
**1. Laboratory Data Standards & Compliance**
· **Map laboratory test names, units, conversion factors, and other parameters to CDISC Standard Controlled Terminology (CT)** across Safety and Efficacy Labs, Biomarkers, Microbiology, Microscopy, Genotyping, Cell Phenotyping, Immune Responses, etc.
· Develop, review, and validate laboratory data mappings for compliance with CDISC Standard Controlled Terminology, SDTM and regulatory requirements (FDA, EMA, PMDA).
· As a Lab expert, contributes to study and/or global request requiring lab expertise.
· Ensure alignment of laboratory data with LOINC and other standard dictionaries.
· Work closely with the Data Integration Team to standardize and map laboratory terminology to CDISC Controlled Terminology.
· Provide recommendations for new or modified laboratory data standards based on industry trends and regulatory requirements.
**2. Laboratory Data Management & Vendor Oversight**
· Act as the Central Lab Co-Business Leader within Trial Operations (TO), overseeing central laboratory service providers.
· Provide direct support to study teams in resolving escalated laboratory data issues.
· Identify high business risk laboratory issues, implement mitigation plans, and coordinate with CQ&CI Management.
· Support vendor qualification, selection, and reassessment of central laboratories for Sanofi studies.
· Ensure laboratory data integrity in file transfer specifications (FTS), collaborating with external vendors and Data Integration teams.
· Represent Clinical Data & AI Processing (CDAIP) in Central Laboratory Governance Meetings and other affiliated working groups.
**3. Cross-functional Collaboration & Study Execution Support**
· Advise Trial Operations, Translational Medicine, and Biomarker teams on laboratory data requirements.
· Collaborate with Sample Management teams on sample handling, tracking, and storage strategies.
· Provide expertise to ensure accurate clinical database setup for laboratory tests, SI units, and conversion factors.
· Participate in regulatory submissions, ensuring laboratory datasets meet CDISC and regulatory requirements.
· Participate in Standards governance reviews to maintain and update standards libraries, ensuring consistency across the clinical lifecycle.
· Support non-standard studies requiring specialized laboratory data handling.
**4. Training, Governance, & Continuous Improvement**
· Develop SOPs, best practices, and training materials for laboratory data standardization.
· Provide training and mentorship on laboratory test mapping processes and CDISC Standard Controlled Terminology (CT) implementation.
· Monitor industry trends, participate in CDISC working groups (including the CT group), and engage with external industry forums.
· Monitor study-specific forms developed with Standard potential at the Therapeutic Area level.
**_About you_**
+ **Experience** : Years of experience in clinical data standards and laboratory data.
+ Strong knowledge of **CDISC SDTM, CDASH, and Standard Controlled Terminology** .
+ Strong experience with **laboratory data** **(Safety and Efficacy Labs, Biomarkers, Microbiology, Microscopy, Genotyping, Cell Phenotyping, Immune Responses, etc.)**
+ Strong understanding and experience with regulatory data submission and requirements.
+ **Strong and clear** understanding of vendor **Laboratory terminology and nomenclature** . As well as Laboratory dictionaries such as **LOINC** .
+ **Soft and technical skills** : Proficiency in data handling tools (Excel, SAS, Python, etc.) for dataset transformation and validation.
+ Familiarity with **MedDRA, WHODrug,** and other clinical terminology standards.
+ Experience with metadata repositories and clinical data management systems **(e.g., Medidata Rave)** is a plus.
+ Certification in **CDISC SDTM, CDASH, or Data Standards** is a plus.
+ Knowledge of regulatory submission requirements (e.g., FDA, PMDA, EMA).
+ Good and clear understanding of vendor **Laboratory terminology and nomenclature**
+ Strong English skills (verbal and written), ability to exchange fluently in a global environment.
+ Ability to negotiate and gain acceptance from others.
+ Ability to coordinate/oversee multiple tasks simultaneously.
+ Project team collaboration by interacting with internal or external partners in/outside the Department and with their leaders.
+ Self-motivated & results driven with attention to detail and quality.
+ Strong analytical and problem-solving skills with high attention to detail.
+ Ability to work independently and collaboratively in a cross-functional team.
+ Excellent communication skills for interacting with technical and non-technical stakeholders.
+ **Education** : Bachelor's degree or above, preferably in Life Science or related field.
+ **Languages** : Excellent English language knowledge - written and spoken.
**_Why choose us?_**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks' gender-neutral parental leave. **"This role is critical to our team's success and provides exposure to industry-wide developments of Data Standards. It is an opportunity to become a leader within a network of subject matter experts collaborating to shape the future of Data Standards for Clinical Research.".**
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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**Job Description Summary**
This analyst role is responsible to perform analysis of stability samples, Raw materials, analytical method validation/verification and method transfer studies
**Job Description**
+ To perform Nitrosamine & extractable and leachable analysis of analytical method development/validation/verification and method transfer.
+ Handling of LCMS, ICPMS instruments.
+ Knowledge on nitrosamine method development/validation/verification.
Experience: 7 to 9 years with M.Sc./ M. Pharm
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.