Job
Description
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 peptideand 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 US and India PolyPeptides 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: Sc 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,
