Sr. Executive – Analytical Development

Job Title: Sr. Executive – Analytical Development (AD)

Location: Ambernath, India

Job Type: Full Time

Reporting: Head of Research & Development

About Polypeptide Group:

PolyPeptide Group AG and its consolidated subsidiaries ("PolyPeptide") is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide's shares (SIX: PPGN) are listed on SIX Swiss Exchange.

Position Overview:

We are looking for a passionate and experienced Sr. Executive – Analytical Development to join our dynamic R&D team. This role is ideal for professionals with a strong foundation in analytical chemistry and a drive to innovate in the peptide and protein space. You will play a key role in developing and validating analytical methods that support cutting-edge pharmaceutical research.

Key Responsibilities:

• Design and develop robust analytical methods for active pharmaceutical ingredients (APIs), in-process materials, and raw materials.
• Optimize and troubleshoot existing methods to enhance accuracy, efficiency, and reliability.
• Lead investigations into method performance issues and analytical discrepancies.
• Conduct method validation and verification in alignment with regulatory standards and internal quality systems.
• Provide comprehensive analytical support for R&D samples, including stability studies.
• Prepare and maintain detailed documentation such as validation protocols, verification reports, and technical summaries.
• Author and update Standard Operating Procedures (SOPs) to ensure consistency and compliance.
• Coordinate with external vendors for instrument calibration and ensure timely execution.
• Oversee IQ, OQ, PQ, and qualification activities for analytical instruments.
• Manage and document stability testing, ensuring accurate tracking and reporting.
• Maintain Annual Maintenance Contract (AMC) records and instrument history logs.
• Troubleshoot analytical instruments and ensure uninterrupted lab operations.
• Uphold Good Laboratory Practices (GLP) and ensure all work complies with approved procedures and quality standards.

Must-Have Qualifications:

• M.Sc. in Analytical/Organic Chemistry or equivalent.
• Minimum 5 years of relevant experience in analytical development.
• Strong background in method development, validation, and troubleshooting.
• Experience in peptide/protein/pharma industries is highly desirable.
• Familiarity with regulatory guidelines and documentation practices.

Preferred Qualifications (Add-ons):

• Hands-on experience with HPLC, GC, UV, IR, and LC-MS instrumentation.
• Familiarity with ICH guidelines and regulatory expectations for method validation and stability studies.
• Exposure to peptide and protein characterization techniques.
• Experience working in regulated environments such as GMP/GLP labs.
• Proficiency in analytical documentation systems and LIMS.
• Ability to manage instrument qualification (IQ/OQ/PQ) and calibration workflows.
• Strong troubleshooting skills for analytical instrumentation and method-related issues.
• Knowledge of stability study protocols and data interpretation.
• Effective communication and collaboration skills for cross-functional R&D support.

Why Join Us at Polypeptide Group:

Polypeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of PolyPeptide team, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies.