Analytical scientist

Job Title: Senior Scientist

Department: Drug Substance Development and Manufacturing (Analytical Development)

Location: Bengaluru, India

About Syngene

At Syngene, Safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’s quality standards always
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

The Scientist in Analytical Development will be responsible for designing, developing, and validating analytical methods to support drug substance development and manufacturing. This role ensures robust analytical strategies are in place to characterize, control, and release drug substances across early- and late-stage development, scale-up, and commercial manufacturing.

📌 Key Responsibilities

• Develop, optimize, and validate analytical methods (chromatography, spectroscopy, wet chemistry, etc.) for drug substance characterization.
• Perform chemical analyses using techniques such as chromatography (HPLC, GC), spectroscopy (UV-Vis, FTIR), and mass spectrometry.
• Perform purification of crude reaction mixtures using preparative HPLC, SFC, flash chromatography, and other chromatographic methods.
• Support structural elucidation and impurity profiling.
• Collaborate cross-functionally with process development, quality, regulatory, and manufacturing teams.
• Ensure methods meet regulatory and quality standards (ICH, FDA, EMA).
• Provide analytical expertise during scale-up and tech transfer to manufacturing sites.
• Ensure compliance with GMP, GLP, and global regulatory guidelines.
• Evaluate and implement new analytical technologies to enhance efficiency and data quality.
• Drive continuous improvement initiatives in analytical workflows.

🧑‍💼 Qualifications

• M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• Experienced in analytical development within the pharmaceutical/biotech industry.
• Strong expertise in chromatographic (HPLC, UPLC, GC), spectroscopic (NMR, MS, UV, IR), and other analytical techniques.
• Proven track record in method development, validation, and regulatory submissions.
• Experience supporting drug substance development from early phase to commercial manufacturing.
• Excellent leadership, communication, and project management skills.

🌟 Desired Attributes

• Strategic thinker with strong problem-solving skills.
• Ability to thrive in a fast-paced, matrixed environment.
• Passion for mentoring and developing scientific talent.
• Strong regulatory awareness and ability to interact with health authorities.

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 about 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.