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.
