Position: Analytical and Formulation Development Scientist (Mid-Senior Level)

Location: Biosimilar Sciences India LLP, Navi-Mumbai.

Reports To: Technical and Operational Head

Job Summary: We are seeking a highly motivated and experienced Analytical and Formulation Development Scientist to join our Research and Development team focused on biosimilar product development. The successful candidate will play a crucial role in the development and characterization of biosimilar products through advanced analytical techniques and formulation strategies. This position requires a deep understanding of bioanalytical methods, biopharmaceutical formulation, and regulatory guidelines.

Key Responsibilities

- Develop and implement analytical methodologies for the characterization of biosimilar products, including techniques such as chromatography (HPLC, UPLC), mass spectrometry, spectroscopy, electrophoresis, and other relevant assays.
- Design, execute, and analyze experiments to evaluate the physicochemical attributes, stability, and comparability of biosimilar candidates against reference products.
- Collaborate with cross-functional teams including biologists, process development scientists, and regulatory affairs personnel to ensure comprehensive understanding and development of biosimilar products.
- Generate, review, and interpret analytical data to assess critical quality attributes (CQAs) and make informed decisions for process optimization and formulation design.
- Lead the formulation development efforts for biosimilar products, utilizing knowledge of excipients, stability-enhancing techniques, and drug delivery systems to achieve desired product profiles.
- Perform forced degradation studies to assess the degradation pathways and stability of biosimilar products under various stress conditions.




- Contribute to the preparation and review of technical documents, including regulatory submissions, development reports, and Standard Operating Procedures (SOPs).
- Stay current with industry trends, regulatory guidelines, and emerging technologies in analytical techniques and biosimilar development.
- Ensure compliance with Good Laboratory Practices (GLP) and other relevant quality standards.

Qualifications and Requirements

· Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Master's degree with substantial relevant experience will also be considered.

· Proven track record of 10+ years in biopharmaceutical analytical and formulation development, with a focus on biosimilar products.

· Strong expertise in various analytical techniques used in the characterization of biologics, including chromatography, mass spectrometry, spectroscopy, and electrophoresis.

· Experience in formulation development, including knowledge of excipient selection, stability studies, and drug delivery systems.

· Familiarity with regulatory guidelines (FDA, EMA, etc.) related to biosimilar development and analytical methods validation.

· Excellent problem-solving skills and the ability to analyze complex data sets to draw meaningful conclusions.

· Effective communication and collaboration skills to work within interdisciplinary teams and present findings internally and externally.

· Hands-on experience with statistical analysis software and data visualization tools is a plus.

· Strong organizational skills and attention to detail to manage multiple projects simultaneously.

Joining our team offers the opportunity to work on cutting-edge biosimilar development projects in a collaborative and agile environment. We are committed to fostering professional growth and innovation while contributing to the advancement of affordable and accessible biologic therapies.

📌 Senior level Scientist in Analytical development f (Mumbai)
🏢 BioSimilar Sciences India
📍 Mumbai