Senior Scientist - Analytical Development

Syngene International; Bengaluru; Presencial; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Syngene International in Bengaluru, India, seeks a Senior Scientist in Analytical Development to design, develop, and validate analytical methods for drug substance characterization and scale-up. You will work across early- to late-stage development, ensuring robust strategies and regulatory compliance.

The role involves leading method development, validating techniques (HPLC/UPLC, GC, NMR, MS), and collaborating with QC, regulatory, and manufacturing teams to support seamless approvals.

Formación

• M.Sc. in Analytical Chemistry or related field.
• 3–9 years of analytical development experience in pharma/biotech.
• Proven method development, validation, and regulatory submissions.

Responsabilidades

• Develop, optimize, and validate analytical methods for drug substance characterization.
• Perform analyses using chromatography, spectroscopy, and MS.
• Purify crude mixtures using preparative HPLC and other chromatographic methods.
• Collaborate with process development, quality, regulatory, and manufacturing teams.
• Ensure methods meet regulatory and GMP/GLP guidelines.

Conocimientos

HPLC

UPLC

GC

NMR

MS

Method Development

Educación

M.Sc. in Analytical Chemistry

Herramientas

HPLC systems

GC systems

Spectroscopy instruments

Descripción del empleo

Job Title: Senior Scientist – Analytical Development

Department: Drug Substance Development and Manufacturing (Analytical Development)

Location: Bengaluru, India

The Senior 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 and scale-up.

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, and other chromatographic methods.
• - Collaborate cross-functionally with process development, quality, regulatory, and manufacturing teams.
• - Ensure methods meet regulatory and quality standards (ICH, FDA, EMA).
• - 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.
• - 3–9 years of experience 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.

Career Impact

This role is pivotal in ensuring the scientific rigor and regulatory compliance of analytical methods that underpin drug substance development and manufacturing. The Senior Scientist will directly influence product quality, patient safety, and successful regulatory approvals.

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.